MedPath

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

Phase 2
Recruiting
Conditions
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Interventions
Procedure: Biospecimen Collection
Other: Best Practice
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Bone Marrow Aspiration
Procedure: Biopsy Procedure
Procedure: Mutation Carrier Screening
Procedure: Bone Marrow Biopsy
Procedure: Echocardiography Test
Procedure: Multigated Acquisition Scan
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Procedure: Chest Radiography
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
Drug: Placebo Administration
Radiation: Total-Body Irradiation
Registration Number
NCT05564390
Lead Sponsor
National Cancer Institute (NCI)
Brief Summary

This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).

Detailed Description

PRIMARY OBJECTIVES:

I. Screening and Reassessment (MSRP): To evaluate the feasibility of MATCHBox receiving and organizing all data needed for assignment to a myeloMATCH clinical trial or Tier Advancement Pathway (TAP) within 72 hours of MDNet receipt of all required specimens for initial therapy and within 10 days for subsequent therapy.

II. Tier Advancement Pathway (TAP): To enable participants who are not matched to an investigational myeloMATCH treatment substudy to receive standard of care (SOC) while remaining on the MSRP to maintain access to later tiers of treatment substudies.

SECONDARY OBJECTIVES:

I. Screening and Reassessment (MSRP):

Ia. To describe the time to generation of all data required for treatment substudy (or TAP) assignment, time to treatment substudy (or TAP) assignment, percent assigned to a myeloMATCH treatment substudy, and the percent of screened participants who register to a myeloMATCH investigational treatment substudy or are assigned to TAP:

Iai. Separately within each tier of myeloMATCH treatment substudy and analogous TAP assignment; Ibi. Separately within each clinical basket of myeloMATCH treatment substudies; Ici. Over time, across and within the categories above.

II. Tier Advancement Pathway (TAP):

IIa. To evaluate participants for assignment to higher tier treatment substudies within myeloMATCH; IIb. To describe, within tier- and basket- levels of TAP, measurable residual disease (MRD) rates and clonal evolution; IIc. To describe, within tier- and basket- levels of TAP, remission status and overall survival of participants who receive standard of care therapy; IId. To obtain MDNet specimens for translational medicine and biobanking.

OUTLINE:

REGISTRATION: Patients undergo bone marrow aspiration and collection of blood on study. Patients' bone marrow and blood specimens undergo rapid genetic testing. Patients are then assigned to a specific substudy containing a therapy targeted to the patient's mutational profile. If there is no targetable mutation, the patient is placed on a substudy testing novel combinations that do not contain a target-specific drug. Patients who are not eligible for any MYELOMATCH substudy are assigned to TAP.

TAP: Patients continue SOC treatment and undergo continued bone marrow aspiration and blood collection for possible future substudy assignment.

TREATMENT: Patients are assigned to a specific treatment substudy.

MM1YA-CTG01: Younger patients (age 18-59 years) with intermediate risk acute myeloid leukemia (AML) are randomized to 1 of 3 arms.

ARM I: Patients receive daunorubicin intravenously (IV), cytarabine IV, and venetoclax orally (PO) on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.

ARM II: Patients receive azacitidine IV or subcutaneously (SC) and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.

ARM III: Patients receive daunorubicin IV and cytarabine IV on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.

MM1YA-S01: Younger patients (age 18-59 years) with high-risk AML are randomized to 1 of 5 arms.

ARM I: Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo echocardiography (ECHO) or multigated acquisition (MUGA) scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

ARM II: Patients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

ARM III: Patients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

ARM IV: Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

MM2YA-EA01: Younger patients (age 18-59 years) with AML or secondary AML who have completed a tier 1 MyeloMATCH treatment study with complete remission (CR) or CR with partial hematologic recovery (CRh) and have detectable minimal residual disease (MRD) (\> 0.1%) are randomized to 1 of 4 arms.

ARM A: Patients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

ARM B: Patients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

ARM C: Patients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

ARM D: Patients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

MM1OA-EA02: Patients are randomized to 1 of 3 regimens.

REGIMEN 1:

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

REGIMEN 2:

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

REGIMEN 3:

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

MM1MDS-A01: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive ASTX727 PO once daily (QD) on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR, CRL, or CRh at the end of cycle 6 may cross-over to Arm B. Patients who experience CR, PR, or stable disease (SD) any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.

ARM B: Patients receive ASTX727 PO QD on days 1-5 and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.

MM1OA-S03: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

ARM 2: Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

MM1YA-A04: Patients are randomized to 1 of 2 regimens.

REGIMEN 1: Patients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.

REGIMEN 2: Patients receive venetoclax PO QD on days 1-11, cytarabine IV, continuously, on days 2-8 and daunorubicin IV on days 2-4 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.

MM3TCT-A03: Patients with matched donors are randomized to conditioning 1A or 1B. Patients with haploidentical or mismatched unrelated donors are randomized to conditioning 2A or 2B.

CONDITIONING 1A: Patients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or twice daily (BID) on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity.

CONDITIONING 1B: Patients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity.

CONDITIONING 2A: Patients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity.

CONDITIONING 2B: Patients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: All patients without evidence of relapse at day +100 are re-randomized to maintenance I or II.

MAINTENANCE I: Patients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity.

MAINTENANCE II: Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity.

Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo positron emission tomography (PET) scan and/or computed tomography (CT) scan throughout the study.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
2000
Inclusion Criteria
  • Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.

  • Participants must be >= 18 years of age.

  • Participants must not have received prior anti-cancer therapy for AML or MDS.

    • Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.
    • Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m^2 of cytarabine, which is allowed for urgent cytoreduction.
  • Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure.

    • Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.
  • Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy

    • Note: active hormonal therapy is allowed
  • Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration.

  • Participants must agree to have translational medicine specimens submitted.

  • Participants must be offered the opportunity to participate in specimen banking.

    • Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP.
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

    • Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
  • The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
MM1MDS-A01 Arm A (ASTX727)Biospecimen CollectionPatients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR, CRL, or CRh at the end of cycle 6 may cross-over to Arm B. Patients who experience CR, PR, or stable disease (SD) any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
MM1MDS-A01 Arm A (ASTX727)Bone Marrow AspirationPatients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR, CRL, or CRh at the end of cycle 6 may cross-over to Arm B. Patients who experience CR, PR, or stable disease (SD) any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
MM1MDS-A01 Arm A (ASTX727)Decitabine and CedazuridinePatients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR, CRL, or CRh at the end of cycle 6 may cross-over to Arm B. Patients who experience CR, PR, or stable disease (SD) any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
MM1MDS-A01 Arm B (ASTX727, enasidenib)Biospecimen CollectionPatients receive ASTX727 PO QD on days 1-5 and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
MM1MDS-A01 Arm B (ASTX727, enasidenib)Bone Marrow AspirationPatients receive ASTX727 PO QD on days 1-5 and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
MM1MDS-A01 Arm B (ASTX727, enasidenib)Decitabine and CedazuridinePatients receive ASTX727 PO QD on days 1-5 and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
MM1MDS-A01 Arm B (ASTX727, enasidenib)EnasidenibPatients receive ASTX727 PO QD on days 1-5 and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.
MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)AzacitidineINDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)Biopsy ProcedureINDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)Biospecimen CollectionINDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)VenetoclaxINDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)AzacitidineINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)Biopsy ProcedureINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)Biospecimen CollectionINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)GilteritinibINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)VenetoclaxINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)AzacitidineINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)Biopsy ProcedureINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)Biospecimen CollectionINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)GilteritinibINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)VenetoclaxINDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
MM1OA-S03 Arm 1 (ASTX727, venetoclax)Biospecimen CollectionPatients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 1 (ASTX727, venetoclax)Bone Marrow AspirationPatients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)Biospecimen CollectionPatients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 1 (ASTX727, venetoclax)Bone Marrow BiopsyPatients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 1 (ASTX727, venetoclax)Decitabine and CedazuridinePatients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 1 (ASTX727, venetoclax)VenetoclaxPatients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)Bone Marrow AspirationPatients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)Bone Marrow BiopsyPatients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)Decitabine and CedazuridinePatients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)EnasidenibPatients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)VenetoclaxPatients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Best PracticePatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Biospecimen CollectionPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Bone Marrow AspirationPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Bone Marrow BiopsyPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)Bone Marrow AspirationPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)Bone Marrow BiopsyPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM2YA-EA01 Arm A (cytarabine)CytarabinePatients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm A (cytarabine)Echocardiography TestPatients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm A (cytarabine)Multigated Acquisition ScanPatients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm B (cytarabine, venetoclax)Biopsy ProcedurePatients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)CytarabinePatients receive daunorubicin IV, cytarabine IV, and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)Daunorubicin HydrochloridePatients receive daunorubicin IV, cytarabine IV, and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)VenetoclaxPatients receive daunorubicin IV, cytarabine IV, and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm II (azacitidine, venetoclax)AzacitidinePatients receive azacitidine IV or SC and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm II (azacitidine, venetoclax)Biospecimen CollectionPatients receive azacitidine IV or SC and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm II (azacitidine, venetoclax)Bone Marrow AspirationPatients receive azacitidine IV or SC and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm II (azacitidine, venetoclax)VenetoclaxPatients receive azacitidine IV or SC and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm III (daunorubicin, cytarabine)Biospecimen CollectionPatients receive daunorubicin IV and cytarabine IV on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm III (daunorubicin, cytarabine)Bone Marrow AspirationPatients receive daunorubicin IV and cytarabine IV on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm III (daunorubicin, cytarabine)CytarabinePatients receive daunorubicin IV and cytarabine IV on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm III (daunorubicin, cytarabine)Daunorubicin HydrochloridePatients receive daunorubicin IV and cytarabine IV on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-S01 Arm I (cytarabine, daunorubicin)Biospecimen CollectionPatients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm I (cytarabine, daunorubicin)Bone Marrow AspirationPatients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm III (azacitidine, venetoclax)Multigated Acquisition ScanPatients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm III (azacitidine, venetoclax)VenetoclaxPatients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm IV (Vyxeos)Biospecimen CollectionPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm IV (Vyxeos)Bone Marrow AspirationPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm IV (Vyxeos)Echocardiography TestPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm IV (Vyxeos)Liposome-encapsulated Daunorubicin-CytarabinePatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm IV (Vyxeos)Multigated Acquisition ScanPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm V (Vyxeos, venetoclax)Biospecimen CollectionPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm V (Vyxeos, venetoclax)Bone Marrow AspirationPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm V (Vyxeos, venetoclax)Echocardiography TestPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm V (Vyxeos, venetoclax)Liposome-encapsulated Daunorubicin-CytarabinePatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm V (Vyxeos, venetoclax)Multigated Acquisition ScanPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm V (Vyxeos, venetoclax)VenetoclaxPatients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM2YA-EA01 Arm A (cytarabine)Biopsy ProcedurePatients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm B (cytarabine, venetoclax)CytarabinePatients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm B (cytarabine, venetoclax)Echocardiography TestPatients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm B (cytarabine, venetoclax)Multigated Acquisition ScanPatients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm B (cytarabine, venetoclax)VenetoclaxPatients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm C (Vyxeos, venetoclax)Biopsy ProcedurePatients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm C (Vyxeos, venetoclax)Echocardiography TestPatients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm C (Vyxeos, venetoclax)Liposome-encapsulated Daunorubicin-CytarabinePatients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm C (Vyxeos, venetoclax)Multigated Acquisition ScanPatients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm C (Vyxeos, venetoclax)VenetoclaxPatients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm D (azacitidine, venetoclax)AzacitidinePatients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm D (azacitidine, venetoclax)Biopsy ProcedurePatients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm D (azacitidine, venetoclax)Echocardiography TestPatients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm D (azacitidine, venetoclax)Multigated Acquisition ScanPatients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM2YA-EA01 Arm D (azacitidine, venetoclax)VenetoclaxPatients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Allogeneic Hematopoietic Stem Cell TransplantationPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Biospecimen CollectionPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Bone Marrow BiopsyPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)BusulfanPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Chest RadiographyPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Computed TomographyPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Echocardiography TestPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)FludarabinePatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MelphalanPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Multigated Acquisition ScanPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)Positron Emission TomographyPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)VenetoclaxPatients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Allogeneic Hematopoietic Stem Cell TransplantationPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Biospecimen CollectionPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Bone Marrow BiopsyPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)BusulfanPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Chest RadiographyPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Computed TomographyPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Echocardiography TestPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)FludarabinePatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)MelphalanPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Multigated Acquisition ScanPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Placebo AdministrationPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 1B (matched donors with placebo)Positron Emission TomographyPatients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Allogeneic Hematopoietic Stem Cell TransplantationPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Biospecimen CollectionPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Bone Marrow BiopsyPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Chest RadiographyPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Computed TomographyPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Echocardiography TestPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)FludarabinePatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MelphalanPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Multigated Acquisition ScanPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Positron Emission TomographyPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)Total-Body IrradiationPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)VenetoclaxPatients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Allogeneic Hematopoietic Stem Cell TransplantationPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Biospecimen CollectionPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Bone Marrow BiopsyPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Chest RadiographyPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Computed TomographyPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Echocardiography TestPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)FludarabinePatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)MelphalanPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Placebo AdministrationPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Positron Emission TomographyPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)Total-Body IrradiationPatients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance I (venetoclax)Biospecimen CollectionPatients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance I (venetoclax)Bone Marrow BiopsyPatients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance I (venetoclax)Computed TomographyPatients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance I (venetoclax)Multigated Acquisition ScanPatients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance I (venetoclax)Positron Emission TomographyPatients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance I (venetoclax)VenetoclaxPatients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance II (placebo)Biospecimen CollectionPatients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance II (placebo)Bone Marrow BiopsyPatients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance II (placebo)Computed TomographyPatients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
TAP (SOC treatment, mutation carrier screening)Mutation Carrier ScreeningPatients continue SOC treatment and undergo continued bone marrow aspiration and blood collection for possible future substudy assignment.
MM3TCT-A03 Maintenance II (placebo)Placebo AdministrationPatients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
MM3TCT-A03 Maintenance II (placebo)Positron Emission TomographyPatients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.
Screening (mutation carrier screening)Mutation Carrier ScreeningPatients undergo bone marrow aspiration and collection of blood on study. Patients' bone marrow and blood specimens undergo rapid genetic testing. Patients are then assigned to a specific substudy containing a therapy targeted to the patient's mutational profile. If there is no targetable mutation, the patient is placed on a substudy testing novel combinations that do not contain a target-specific drug. Patients who are not eligible for any MYELOMATCH substudy are assigned to TAP.
TAP (SOC treatment, mutation carrier screening)Best PracticePatients continue SOC treatment and undergo continued bone marrow aspiration and blood collection for possible future substudy assignment.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)CytarabinePatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Daunorubicin HydrochloridePatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Echocardiography TestPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Gemtuzumab OzogamicinPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Multigated Acquisition ScanPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)Best PracticePatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)Biospecimen CollectionPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)CytarabinePatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)Daunorubicin HydrochloridePatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)Echocardiography TestPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)Multigated Acquisition ScanPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)VenetoclaxPatients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)Biospecimen CollectionPatients receive daunorubicin IV, cytarabine IV, and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)Bone Marrow AspirationPatients receive daunorubicin IV, cytarabine IV, and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
MM1YA-S01 Arm III (azacitidine, venetoclax)Bone Marrow AspirationPatients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm I (cytarabine, daunorubicin)CytarabinePatients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm I (cytarabine, daunorubicin)Daunorubicin HydrochloridePatients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm I (cytarabine, daunorubicin)Echocardiography TestPatients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm I (cytarabine, daunorubicin)Multigated Acquisition ScanPatients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)Biospecimen CollectionPatients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)Bone Marrow AspirationPatients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm III (azacitidine, venetoclax)Echocardiography TestPatients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)CytarabinePatients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)Daunorubicin HydrochloridePatients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)Echocardiography TestPatients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)Multigated Acquisition ScanPatients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)VenetoclaxPatients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm III (azacitidine, venetoclax)AzacitidinePatients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
MM1YA-S01 Arm III (azacitidine, venetoclax)Biospecimen CollectionPatients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Primary Outcome Measures
NameTimeMethod
Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignmentWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Will evaluate the feasibility of MATCHBox generating all data needed for assignment to a myeloMATCH clinical trial or determination that no assignment is available, within 72 hours of MDNet receipt of specimens for initial therapy and within 10 days for subsequent therapy. For first treatment assignment and separately for each subsequent treatment assignments: every 50 participants for the first 250 participants and then every 100 participants thereafter, the proportion of participants (cumulative and new participants since prior analysis) with all MDNet data needed to determine a treatment assignment within 72 hours for first assignment and 10 days for subsequent assignments after the MDNet receives specimens will be tallied.

Secondary Outcome Measures
NameTimeMethod
Minimal residual disease (MRD) responseWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

MRD response is based on flow cytometry studies performed by the MDnet.

Time-to-event outcomes for exploratory analysisWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Time to MDNet generating all data required for treatment substudy or TAP assignmentWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Performance statusWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Participants will be graded according to the Zubrod performance status scale.

Percent of screened participants who register to a treatment substudyWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Time to treatment substudy or TAP assignmentWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Percent assigned to a myeloMATCH clinical trialWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Assignment to higher tier treatment substudies within myeloMATCHWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Adverse eventsWithin 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Will be assessed within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 month intervals from study opening).

Trial Locations

Locations (278)

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Mercy Hospital South

🇺🇸

Saint Louis, Missouri, United States

Siteman Cancer Center-South County

🇺🇸

Saint Louis, Missouri, United States

Missouri Baptist Medical Center

🇺🇸

Saint Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

🇺🇸

Saint Louis, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital

🇺🇸

Saint Peters, Missouri, United States

Sainte Genevieve County Memorial Hospital

🇺🇸

Sainte Genevieve, Missouri, United States

Missouri Baptist Sullivan Hospital

🇺🇸

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

🇺🇸

Sunset Hills, Missouri, United States

Community Hospital of Anaconda

🇺🇸

Anaconda, Montana, United States

Billings Clinic Cancer Center

🇺🇸

Billings, Montana, United States

Bozeman Health Deaconess Hospital

🇺🇸

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

🇺🇸

Great Falls, Montana, United States

Logan Health Medical Center

🇺🇸

Kalispell, Montana, United States

Saint Patrick Hospital - Community Hospital

🇺🇸

Missoula, Montana, United States

Community Medical Center

🇺🇸

Toms River, New Jersey, United States

Nebraska Medicine-Bellevue

🇺🇸

Bellevue, Nebraska, United States

Nebraska Medicine-Village Pointe

🇺🇸

Omaha, Nebraska, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

OptumCare Cancer Care at Seven Hills

🇺🇸

Henderson, Nevada, United States

OptumCare Cancer Care at Charleston

🇺🇸

Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache

🇺🇸

Las Vegas, Nevada, United States

Memorial Sloan Kettering Basking Ridge

🇺🇸

Basking Ridge, New Jersey, United States

Saint Barnabas Medical Center

🇺🇸

Livingston, New Jersey, United States

Monmouth Medical Center

🇺🇸

Long Branch, New Jersey, United States

Memorial Sloan Kettering Monmouth

🇺🇸

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

🇺🇸

Montvale, New Jersey, United States

Rutgers Cancer Institute of New Jersey

🇺🇸

New Brunswick, New Jersey, United States

University of New Mexico Cancer Center

🇺🇸

Albuquerque, New Mexico, United States

Montefiore Medical Center - Moses Campus

🇺🇸

Bronx, New York, United States

Memorial Sloan Kettering Commack

🇺🇸

Commack, New York, United States

Northwell Health/Center for Advanced Medicine

🇺🇸

Lake Success, New York, United States

North Shore University Hospital

🇺🇸

Manhasset, New York, United States

Mount Sinai Hospital

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

Rochester General Hospital

🇺🇸

Rochester, New York, United States

University of Rochester

🇺🇸

Rochester, New York, United States

State University of New York Upstate Medical University

🇺🇸

Syracuse, New York, United States

Memorial Sloan Kettering Nassau

🇺🇸

Uniondale, New York, United States

UNC Lineberger Comprehensive Cancer Center

🇺🇸

Chapel Hill, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute

🇺🇸

Charlotte, North Carolina, United States

Novant Health Presbyterian Medical Center

🇺🇸

Charlotte, North Carolina, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

Novant Health Forsyth Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

Wake Forest University Health Sciences

🇺🇸

Winston-Salem, North Carolina, United States

Case Western Reserve University

🇺🇸

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

🇺🇸

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

🇺🇸

Oklahoma City, Oklahoma, United States

Providence Newberg Medical Center

🇺🇸

Newberg, Oregon, United States

Saint Alphonsus Cancer Care Center-Ontario

🇺🇸

Ontario, Oregon, United States

Providence Willamette Falls Medical Center

🇺🇸

Oregon City, Oregon, United States

Providence Portland Medical Center

🇺🇸

Portland, Oregon, United States

Providence Saint Vincent Medical Center

🇺🇸

Portland, Oregon, United States

Oregon Health and Science University

🇺🇸

Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest

🇺🇸

Allentown, Pennsylvania, United States

Geisinger Medical Center

🇺🇸

Danville, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

🇺🇸

Pittsburgh, Pennsylvania, United States

Reading Hospital

🇺🇸

West Reading, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

🇺🇸

Wilkes-Barre, Pennsylvania, United States

Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

Prisma Health Cancer Institute - Spartanburg

🇺🇸

Boiling Springs, South Carolina, United States

Prisma Health Cancer Institute - Easley

🇺🇸

Easley, South Carolina, United States

Prisma Health Cancer Institute - Butternut

🇺🇸

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris

🇺🇸

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

🇺🇸

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Greer

🇺🇸

Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca

🇺🇸

Seneca, South Carolina, United States

Sanford Cancer Center Oncology Clinic

🇺🇸

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

🇺🇸

Sioux Falls, South Dakota, United States

Baptist Memorial Hospital and Cancer Center-Collierville

🇺🇸

Collierville, Tennessee, United States

University of Tennessee - Knoxville

🇺🇸

Knoxville, Tennessee, United States

Baptist Memorial Hospital and Cancer Center-Memphis

🇺🇸

Memphis, Tennessee, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

🇺🇸

Houston, Texas, United States

Ben Taub General Hospital

🇺🇸

Houston, Texas, United States

Huntsman Cancer Institute/University of Utah

🇺🇸

Salt Lake City, Utah, United States

George E Wahlen Department of Veterans Affairs Medical Center

🇺🇸

Salt Lake City, Utah, United States

University of Vermont Medical Center

🇺🇸

Burlington, Vermont, United States

University of Vermont and State Agricultural College

🇺🇸

Burlington, Vermont, United States

University of Virginia Cancer Center

🇺🇸

Charlottesville, Virginia, United States

Inova Schar Cancer Institute

🇺🇸

Fairfax, Virginia, United States

Inova Fairfax Hospital

🇺🇸

Falls Church, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center

🇺🇸

Richmond, Virginia, United States

Swedish Cancer Institute-Edmonds

🇺🇸

Edmonds, Washington, United States

Swedish Cancer Institute-Issaquah

🇺🇸

Issaquah, Washington, United States

Swedish Medical Center-First Hill

🇺🇸

Seattle, Washington, United States

ThedaCare Regional Cancer Center

🇺🇸

Appleton, Wisconsin, United States

Duluth Clinic Ashland

🇺🇸

Ashland, Wisconsin, United States

Aurora Cancer Care-Southern Lakes VLCC

🇺🇸

Burlington, Wisconsin, United States

Aurora Saint Luke's South Shore

🇺🇸

Cudahy, Wisconsin, United States

Marshfield Medical Center-EC Cancer Center

🇺🇸

Eau Claire, Wisconsin, United States

Aurora Health Care Germantown Health Center

🇺🇸

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

🇺🇸

Grafton, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay

🇺🇸

Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Saint Mary's

🇺🇸

Green Bay, Wisconsin, United States

Aurora BayCare Medical Center

🇺🇸

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

🇺🇸

Kenosha, Wisconsin, United States

Gundersen Lutheran Medical Center

🇺🇸

La Crosse, Wisconsin, United States

William S Middleton VA Medical Center

🇺🇸

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

🇺🇸

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

🇺🇸

Madison, Wisconsin, United States

Aurora Bay Area Medical Group-Marinette

🇺🇸

Marinette, Wisconsin, United States

Marshfield Medical Center-Marshfield

🇺🇸

Marshfield, Wisconsin, United States

Aurora Cancer Care-Milwaukee

🇺🇸

Milwaukee, Wisconsin, United States

Aurora Saint Luke's Medical Center

🇺🇸

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

🇺🇸

Milwaukee, Wisconsin, United States

Marshfield Medical Center - Minocqua

🇺🇸

Minocqua, Wisconsin, United States

ProHealth D N Greenwald Center

🇺🇸

Mukwonago, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

🇺🇸

Oconomowoc, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Oconto Falls

🇺🇸

Oconto Falls, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh

🇺🇸

Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine

🇺🇸

Racine, Wisconsin, United States

Marshfield Medical Center-Rice Lake

🇺🇸

Rice Lake, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Sheboygan

🇺🇸

Sheboygan, Wisconsin, United States

Vince Lombardi Cancer Clinic-Sheboygan

🇺🇸

Sheboygan, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

🇺🇸

Stevens Point, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

🇺🇸

Sturgeon Bay, Wisconsin, United States

Aurora Medical Center in Summit

🇺🇸

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers

🇺🇸

Two Rivers, Wisconsin, United States

ProHealth Waukesha Memorial Hospital

🇺🇸

Waukesha, Wisconsin, United States

UW Cancer Center at ProHealth Care

🇺🇸

Waukesha, Wisconsin, United States

Aurora Cancer Care-Milwaukee West

🇺🇸

Wauwatosa, Wisconsin, United States

Aurora West Allis Medical Center

🇺🇸

West Allis, Wisconsin, United States

Marshfield Medical Center - Weston

🇺🇸

Weston, Wisconsin, United States

Arthur J E Child Comprehensive Cancer Centre

🇨🇦

Calgary, Alberta, Canada

CancerCare Manitoba

🇨🇦

Winnipeg, Manitoba, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

🇨🇦

Hamilton, Ontario, Canada

CSSS Champlain-Charles Le Moyne

🇨🇦

Greenfield Park, Quebec, Canada

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

🇨🇦

Montreal, Quebec, Canada

Jewish General Hospital

🇨🇦

Montreal, Quebec, Canada

Centro Comprensivo de Cancer de UPR

🇵🇷

San Juan, Puerto Rico

San Juan City Hospital

🇵🇷

San Juan, Puerto Rico

University of Alabama at Birmingham Cancer Center

🇺🇸

Birmingham, Alabama, United States

Banner University Medical Center - Tucson

🇺🇸

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

🇺🇸

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Kaiser Permanente Dublin

🇺🇸

Dublin, California, United States

Kaiser Permanente-Fremont

🇺🇸

Fremont, California, United States

Kaiser Permanente-Fresno

🇺🇸

Fresno, California, United States

Tibor Rubin VA Medical Center

🇺🇸

Long Beach, California, United States

Cedars Sinai Medical Center

🇺🇸

Los Angeles, California, United States

Kaiser Permanente-Modesto

🇺🇸

Modesto, California, United States

Kaiser Permanente-Oakland

🇺🇸

Oakland, California, United States

Kaiser Permanente-Roseville

🇺🇸

Roseville, California, United States

Kaiser Permanente Downtown Commons

🇺🇸

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

🇺🇸

Sacramento, California, United States

Kaiser Permanente-South Sacramento

🇺🇸

Sacramento, California, United States

Kaiser Permanente-San Francisco

🇺🇸

San Francisco, California, United States

UCSF Medical Center-Parnassus

🇺🇸

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

🇺🇸

San Jose, California, United States

Kaiser Permanente San Leandro

🇺🇸

San Leandro, California, United States

Kaiser San Rafael-Gallinas

🇺🇸

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

🇺🇸

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

🇺🇸

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

🇺🇸

South San Francisco, California, United States

Kaiser Permanente-Vallejo

🇺🇸

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

🇺🇸

Walnut Creek, California, United States

Yale University

🇺🇸

New Haven, Connecticut, United States

Veterans Affairs Connecticut Healthcare System-West Haven Campus

🇺🇸

West Haven, Connecticut, United States

Augusta University Medical Center

🇺🇸

Augusta, Georgia, United States

Kaiser Permanente Moanalua Medical Center

🇺🇸

Honolulu, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

🇺🇸

Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise

🇺🇸

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

🇺🇸

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

🇺🇸

Coeur d'Alene, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

🇺🇸

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

🇺🇸

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

🇺🇸

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Nampa

🇺🇸

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

🇺🇸

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

🇺🇸

Sandpoint, Idaho, United States

OSF Saint Joseph Medical Center

🇺🇸

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

🇺🇸

Bloomington, Illinois, United States

Illinois CancerCare-Canton

🇺🇸

Canton, Illinois, United States

Illinois CancerCare-Carthage

🇺🇸

Carthage, Illinois, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

🇺🇸

Chicago, Illinois, United States

Carle at The Riverfront

🇺🇸

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

🇺🇸

Decatur, Illinois, United States

Decatur Memorial Hospital

🇺🇸

Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

🇺🇸

DeKalb, Illinois, United States

Illinois CancerCare-Dixon

🇺🇸

Dixon, Illinois, United States

Carle Physician Group-Effingham

🇺🇸

Effingham, Illinois, United States

Crossroads Cancer Center

🇺🇸

Effingham, Illinois, United States

Illinois CancerCare-Eureka

🇺🇸

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

🇺🇸

Evanston, Illinois, United States

Illinois CancerCare-Galesburg

🇺🇸

Galesburg, Illinois, United States

Northwestern Medicine Cancer Center Delnor

🇺🇸

Geneva, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

🇺🇸

Glenview, Illinois, United States

Northwestern Medicine Glenview Outpatient Center

🇺🇸

Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center

🇺🇸

Grayslake, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

🇺🇸

Highland Park, Illinois, United States

Illinois CancerCare-Kewanee Clinic

🇺🇸

Kewanee, Illinois, United States

Northwestern Medicine Lake Forest Hospital

🇺🇸

Lake Forest, Illinois, United States

Illinois CancerCare-Macomb

🇺🇸

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

🇺🇸

Mattoon, Illinois, United States

Loyola University Medical Center

🇺🇸

Maywood, Illinois, United States

Cancer Care Center of O'Fallon

🇺🇸

O'Fallon, Illinois, United States

Northwestern Medicine Orland Park

🇺🇸

Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic

🇺🇸

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

🇺🇸

Pekin, Illinois, United States

Illinois CancerCare-Peoria

🇺🇸

Peoria, Illinois, United States

Methodist Medical Center of Illinois

🇺🇸

Peoria, Illinois, United States

OSF Saint Francis Medical Center

🇺🇸

Peoria, Illinois, United States

Illinois CancerCare-Peru

🇺🇸

Peru, Illinois, United States

Illinois CancerCare-Princeton

🇺🇸

Princeton, Illinois, United States

Southern Illinois University School of Medicine

🇺🇸

Springfield, Illinois, United States

Springfield Clinic

🇺🇸

Springfield, Illinois, United States

Springfield Memorial Hospital

🇺🇸

Springfield, Illinois, United States

Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

🇺🇸

Warrenville, Illinois, United States

Illinois CancerCare - Washington

🇺🇸

Washington, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

🇺🇸

Indianapolis, Indiana, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

🇺🇸

Clive, Iowa, United States

Mercy Medical Center - Des Moines

🇺🇸

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

🇺🇸

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

🇺🇸

Iowa City, Iowa, United States

University of Kansas Clinical Research Center

🇺🇸

Fairway, Kansas, United States

HaysMed

🇺🇸

Hays, Kansas, United States

University of Kansas Cancer Center

🇺🇸

Kansas City, Kansas, United States

Lawrence Memorial Hospital

🇺🇸

Lawrence, Kansas, United States

The University of Kansas Cancer Center - Olathe

🇺🇸

Olathe, Kansas, United States

University of Kansas Cancer Center-Overland Park

🇺🇸

Overland Park, Kansas, United States

University of Kansas Hospital-Indian Creek Campus

🇺🇸

Overland Park, Kansas, United States

Salina Regional Health Center

🇺🇸

Salina, Kansas, United States

Cotton O'Neil Cancer Center / Stormont Vail Health

🇺🇸

Topeka, Kansas, United States

University of Kansas Health System Saint Francis Campus

🇺🇸

Topeka, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

🇺🇸

Westwood, Kansas, United States

University of Kentucky/Markey Cancer Center

🇺🇸

Lexington, Kentucky, United States

The James Graham Brown Cancer Center at University of Louisville

🇺🇸

Louisville, Kentucky, United States

UofL Health Medical Center Northeast

🇺🇸

Louisville, Kentucky, United States

LSU Health Baton Rouge-North Clinic

🇺🇸

Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group

🇺🇸

Baton Rouge, Louisiana, United States

Our Lady of The Lake

🇺🇸

Baton Rouge, Louisiana, United States

Mid Coast Hospital

🇺🇸

Brunswick, Maine, United States

MaineHealth Maine Medical Center - Portland

🇺🇸

Portland, Maine, United States

MaineHealth Cancer Care and IV Therapy - South Portland

🇺🇸

South Portland, Maine, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

🇺🇸

Baltimore, Maryland, United States

Tufts Medical Center

🇺🇸

Boston, Massachusetts, United States

UMass Memorial Medical Center - University Campus

🇺🇸

Worcester, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

🇺🇸

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

🇺🇸

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

🇺🇸

Canton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

🇺🇸

Chelsea, Michigan, United States

Wayne State University/Karmanos Cancer Institute

🇺🇸

Detroit, Michigan, United States

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

🇺🇸

Farmington Hills, Michigan, United States

Cancer Hematology Centers - Flint

🇺🇸

Flint, Michigan, United States

Genesee Hematology Oncology PC

🇺🇸

Flint, Michigan, United States

Genesys Hurley Cancer Institute

🇺🇸

Flint, Michigan, United States

Hurley Medical Center

🇺🇸

Flint, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

🇺🇸

Livonia, Michigan, United States

Henry Ford Medical Center-Columbus

🇺🇸

Novi, Michigan, United States

Henry Ford West Bloomfield Hospital

🇺🇸

West Bloomfield, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

🇺🇸

Ypsilanti, Michigan, United States

Mercy Hospital

🇺🇸

Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic

🇺🇸

Deer River, Minnesota, United States

Essentia Health Cancer Center

🇺🇸

Duluth, Minnesota, United States

Fairview Southdale Hospital

🇺🇸

Edina, Minnesota, United States

Essentia Health Hibbing Clinic

🇺🇸

Hibbing, Minnesota, United States

Abbott-Northwestern Hospital

🇺🇸

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

🇺🇸

Saint Louis Park, Minnesota, United States

United Hospital

🇺🇸

Saint Paul, Minnesota, United States

Essentia Health Virginia Clinic

🇺🇸

Virginia, Minnesota, United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

🇺🇸

Columbus, Mississippi, United States

Baptist Cancer Center-Grenada

🇺🇸

Grenada, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Union County

🇺🇸

New Albany, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Oxford

🇺🇸

Oxford, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Desoto

🇺🇸

Southhaven, Mississippi, United States

Siteman Cancer Center at West County Hospital

🇺🇸

Creve Coeur, Missouri, United States

Parkland Health Center - Farmington

🇺🇸

Farmington, Missouri, United States

University Health Truman Medical Center

🇺🇸

Kansas City, Missouri, United States

University of Kansas Cancer Center - North

🇺🇸

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

🇺🇸

Lee's Summit, Missouri, United States

Heartland Regional Medical Center

🇺🇸

Saint Joseph, Missouri, United States

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