A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

Phase 3

Completed

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: azacitidine
Drug: glasdegib
Drug: daunorubicin + cytarabine
Drug: Placebo
Drug: cytarabine
Procedure: HSCT

Registration Number: NCT03416179

Lead Sponsor: Pfizer

Brief Summary: Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).

Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).

Detailed Description: Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.

Assignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.

Study B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.

Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).

Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 730

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):

Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with:
- AML arising from MDS or another antecedent hematologic disease (AHD).
- AML after previous cytotoxic therapy or radiation (secondary AML).
18 years of age (In Japan, 20 years of age).
Adequate Organ Function as defined by the following:
- Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.
- Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).
- Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.
QTc interval 470 msec using the Fridericia correction (QTcF).
All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines.
- For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.
Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.
Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.
Female subjects of non childbearing potential must meet at least 1 of the following criteria:
1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
2. Have medically confirmed ovarian failure; or
3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).

Exclusion Criteria

Subjects with any of the following characteristics/conditions will not be included in the study:

Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).
AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality.
- Complex genetics may include t(9;22) cytogenetic translocation.
Subjects with known active CNS leukemia.
Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.
Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.
Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.
Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.
Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.
Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.
Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.
Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.
Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.
Concurrent administration of herbal preparations.
Major surgery or radiation within 4 weeks of starting study treatment.
Documented or suspected hypersensitivity to any one of the following:
- For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.
- For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.
Known active drug or alcohol abuse.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Pregnant females or breastfeeding female subjects.
Known recent or active suicidal ideation or behavior.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (Intensive Study)	daunorubicin + cytarabine	Glasdegib + '7+3' Induction(s)
Arm B (Intensive Study)	daunorubicin + cytarabine	Placebo + '7+3' Induction(s)
Arm B (Intensive Study)	Placebo	Placebo + '7+3' Induction(s)
Arm A (Intensive Study)	HSCT	Glasdegib + '7+3' Induction(s)
Arm B (Intensive Study)	HSCT	Placebo + '7+3' Induction(s)
Arm A (Non-intensive study)	azacitidine	Glasdegib + azacitidine
Arm B (Non-intensive study)	Placebo	Placebo + azacitidine
Arm A (Intensive Study)	glasdegib	Glasdegib + '7+3' Induction(s)
Arm A (Intensive Study)	cytarabine	Glasdegib + '7+3' Induction(s)
Arm B (Intensive Study)	cytarabine	Placebo + '7+3' Induction(s)
Arm B (Non-intensive study)	azacitidine	Placebo + azacitidine
Arm A (Non-intensive study)	glasdegib	Glasdegib + azacitidine

Primary Outcome Measures

Name	Time	Method
Intensive Study: Overall Survival (OS)	Baseline up to 25 months	OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.
Non-intensive Study: Overall Survival (OS)	Baseline up to 25 months	OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.

Secondary Outcome Measures

Name	Time	Method
Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire	Post-baseline up to Week 8	MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). "Fatigue" was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 numeric rating scale (NRS), where 0 = "not present" and 10 = "as bad as you can imagine". Percentage of participants who had improvement in "fatigue" symptoms reported in this outcome measure.
Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12	Post-baseline up to Week 12	MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). "Fatigue" was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = "not present" and 10 = "as bad as you can imagine". Percentage of participants who had improvement in "fatigue" symptoms reported in this outcome measure.
Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg)	Day 1 up to maximum of 2 years	CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\10\^9/L; platelet count \>=100\10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC.
Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)	Day 1 up to maximum of 2 years	MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods.
Intensive Study: Percentage of Participants With Partial Remission (PR)	Day 1 up to maximum of 2 years	PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\10\^9/L; and platelets count \>=100\10\^9/L.
Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)	Day 1 up to maximum of 2 years	Complete remission (CR) was defined based on 2017 European LeukemiaNet (ELN) recommendations. CR: Bone marrow blasts \<5 percentage (%); absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) greater than equal to (\>=) 1.0\10\^9/Liter (L); platelet count \>=100\10\^9/L. CRMRD-neg: CR with negativity for a genetic marker by reverse transcription quantitative polymerase chain reaction (RT-qPCR), or CR with negativity by Multiparameter Flow Cytometry (MFC).
Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg)	Day 1 up to maximum of 3 years	CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\10\^9/L; platelet count \>=100\10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC.
Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)	Day 1 up to maximum of 3 years	MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods.
Non-intensive Study: Percentage of Participants With Partial Remission (PR)	Day 1 up to maximum of 3 years	PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\10\^9/L; and platelets count \>=100\10\^9/L.
Intensive Study: Duration of Response (DoRi)	From date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause (maximum up to 2 years)	DoRi: only defined for participants who have ever achieved CRi or better (included CR as well) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. CRi: not qualifying for CR, neutropenia \<1.0\10\^9/L or platelets \<100\10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\10\^9/L; platelet count \>=100\10\^9/L. Participants last known to be alive who were free from relapse after CRi or better were censored at the date of last disease assessment that verifies their status.
Non-intensive Study: Duration of Response (DoRi) or (DoRh)	From date of first achieving CRi/CRh or better to the date of relapse/disease progression after CRi/CRh or better or death due to any cause (maximum up to 3 years)	DoRi: only defined for participants who have ever achieved CRi or better (included CR and CRh) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. DoRh: participants who had ever achieved CRh or better (included CR) on study as the time from date of first achieving CRh or better to the date of disease progression, or relapse after CRh or better, or death due to any cause. CRi: not qualifying for CR, neutrophil \<0.5\10\^9/L or platelets \<50\10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\10\^9/L and platelets \>=50\10\^9/L must be met, but does not satisfy both neutrophils \>=1\10\^9/L and platelets \>=100\10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.
Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)	Day 1 up to maximum of 3 years	CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\10\^9/L; platelet count \>=100\10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC.
Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)	Day 1 up to maximum of 2 years	CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC less than (\<) 1.0\10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutropenia \<1.0\10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods.
Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)	Day 1 up to maximum of 3 years	CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \<1.0\10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutrophil \<0.5\10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods.
Intensive Study: Participants Global Impression of Change (PGIC)	Day 1 up to maximum of 2 years	PGIC: a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 7-point Likert scale anchored by (1) 'very much improved' to (7) 'very much worse', with (4) =' no change'. The PGIC is a measure of "participant rating of global improvement and satisfaction with treatment".
Non-intensive Study: Participants Global Impression of Change (PGIC)	Day 1 up to maximum of 3 years	PGIC: a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 7-point Likert scale anchored by (1) 'very much improved' to (7) 'very much worse', with (4) =' no change'. The PGIC is a measure of "participant rating of global improvement and satisfaction with treatment".
Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 2 years	AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. AEs included SAEs and all non-SAEs. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.
Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 3 years	AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. AEs included SAEs and all non-SAEs. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.
Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 2 years	A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.
Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 3 years	A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. NCI CTCAE v4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 2 years	Hematology laboratory test included: anemia, hemoglobin increased, international normalized ratio (INR) increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for hematology laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)	Day 1 up to maximum of 3 years	CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\10\^9/L and platelets \>=50\10\^9/L must be met, but does not satisfy both neutrophils \>=1\10\^9/L and platelets \>=100\10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.
Non-intensive Study: Time to Response	From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years)	TTRi:Participants who achieved CRi or better, as the time from date of randomization to first documentation of response(CRi or better).TTRh:Participants who achieved CRh or better, as the time from date of randomization to first documentation of response(CRh or better). CRi:not qualifying for CR, neutrophil\<0.5\10\^9/L or platelets\<50\10\^9, absence of extramedullary disease,absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\10\^9/L; platelet count \>=100\10\^9/L. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\10\^9/L and platelets \>=50\10\^9/L must be met, but does not satisfy both neutrophils \>=1\10\^9/L and platelets \>=100\10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.
Intensive Study: Event-free Survival (EFS)	From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 2 years)	EFS: Time from the date of randomization to the date of treatment failure (TF), relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\10\^9/L; platelet count \>=100\10\^9/L.
Intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score	Day 1 up to maximum of 2 years	MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). The 13 core symptoms and 6 core interference items had highest frequency and/or severity in participants with various cancers and treatment types. It was measured at severity of symptoms and related interference at their worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = "not present" or "did not interfere" and 10 = "worst" or "interfered completely".
Non-intensive Study: Event-free Survival (EFS)	From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 3 years)	EFS: Time from the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\10\^9/L; platelet count \>=100\10\^9/L.
Non-intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score	Day 1 up to maximum of 3 years	MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). The 13 core symptoms and 6 core interference items had highest frequency and/or severity in participants with various cancers and treatment types. It was measured at severity of symptoms and related interference at their worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = "not present" or "did not interfere" and 10 = "worst" or "interfered completely".
Intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score	Day 1 up to maximum of 2 years	EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), the EuroQoL visual analogue scale (EQ-VAS). EQ-5D: descriptive system measures a participant's health state on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participant is asked to indicate his/her health state by rating each dimension on a 5-level scale (1=no problem, 5=extreme problem). This rating resulted in a 1-digit number expressing the level selected for that dimension. The digits for the 5 dimensions were combined in a 5-digit number describing the respondent's health state. The EQ-5D index scores ranges from 0 to 1, with 0=worst health state and 1=perfect health.
Non-intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score	Day 1 up to maximum of 3 years	EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ-5D: descriptive system measures a participant's health state on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participant is asked to indicate his/her health state by rating each dimension on a 5-level scale (1=no problem, 5=extreme problem). This rating resulted in a 1-digit number expressing the level selected for that dimension. The digits for the 5 dimensions were combined in a 5-digit number describing the respondent's health state. The EQ-5D index scores ranges from 0 to 1, with 0=worst health state and 1=perfect health.
Intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS)	Day 1 up to maximum of 2 years	EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ VAS records the respondent's self-rated health on a 20-cm vertical, VAS from 0 (worst imaginable health state) to 100 (best imaginable health state).
Non-intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS)	Day 1 up to maximum of 3 years	EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ VAS records the respondent's self-rated health on a 20-cm vertical, VAS from 0 (worst imaginable health state) to 100 (best imaginable health state).
Intensive Study: Participants Global Impression of Symptoms (PGIS)	Day 1 up to maximum of 2 years	PGIS: is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time. It uses a 4-point Likert scale as follows: In the last 24 hours, symptoms are: 1-"absent (no symptoms)", 2-"mild", 3-" moderate", 4="severe".
Non-intensive Study: Participants Global Impression of Symptoms (PGIS)	Day 1 up to maximum of 3 years	PGIS: is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time. It uses a 4-point Likert scale as follows: In the last 24 hours, symptoms are: 1-"absent (no symptoms)", 2-"mild", 3-" moderate", 4="severe".
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 3 years	Hematology laboratory test included: anemia, hemoglobin increased, INR increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for hematology laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 2 years	Chemistry laboratory test included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, chronic kidney disease, creatine phosphokinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for chemistry laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 3 years	Chemistry laboratory test included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, chronic kidney disease, CPK increased, creatinine increased, GGT increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for chemistry laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 2 years	Coagulation laboratory test included: activated partial thromboplastin time prolonged, and INR increased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 0= no abnormality; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for coagulation were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03	Day 1 up to maximum of 3 years	Coagulation laboratory test included: activated partial thromboplastin time prolonged, and INR increased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 0= no abnormality; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for coagulation were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.
Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib	Induction, Day 10+/-1: pre-dose, 1, 4 hour (hr); Consolidation phase, Day 1: pre-dose, 1, 4 hr	Ctrough of Glasdegib was measured in nanogram per milliliter (ng/mL).
Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib	Pre-dose: Cycle 1 Day 15 and Cycle 2 Day 1	Ctrough of Glasdegib was measured in ng/mL.
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval	Day 1 up to maximum of 2 years	Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of \<=450 to \>500 msec (post-baseline) were summarized. Number of participants with shift from baseline for QTc were assessed. Only those QTc parameters in which at least 1 participant had data were reported.
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval	Day 1 up to maximum of 3 years	Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of \<=450 to \>500 msec (post-baseline) were summarized. Number of participants with shift from baseline for QTc were assessed. Only those QTc parameters in which at least 1 participant had data were reported.

Trial Locations

Locations (149): Baylor University Medical Center
🇺🇸
Dallas, Texas, United States
Princess Margaret Cancer Centre
🇨🇦
Toronto, Ontario, Canada
WWCOiT im. M. Kopernika w Lodzi
🇵🇱
Lodz, Poland
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
🇵🇱
Gdansk, Poland
Chang Gung Memorial Hospital-Linkou Branch
🇨🇳
Taoyuan City, Taiwan
UCLA Drug Information/Investigational Drugs
🇺🇸
Los Angeles, California, United States
UCLA Hematology/Oncology Clinic
🇺🇸
Los Angeles, California, United States
Universitaire Ziekenhuizen Leuven
🇧🇪
Leuven, Belgium
UCLA Ronald Reagan Medical Center
🇺🇸
Los Angeles, California, United States
Georgia Cancer Center at Augusta University
🇺🇸
Augusta, Georgia, United States
UCLA Department of Medicine
🇺🇸
Los Angeles, California, United States
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
🇦🇹
Wien, Austria
Universitetssjukhuset Orebro
🇸🇪
Orebro, Sweden
Augusta University Medical Center
🇺🇸
Augusta, Georgia, United States
AZ Sint-Jan Brugge-Oostende av
🇧🇪
Brugge, Belgium
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Universitaire Ziekenhuizen Brussel
🇧🇪
Brussels, Belgium
Health Sciences Centre
🇨🇦
Winnipeg, Manitoba, Canada
Ústavni lékárna
🇨🇿
Praha 10, Czechia
CHU de Nantes
🇫🇷
Nantes cedex 1, France
Philipps-Universitaet Marburg
🇩🇪
Marburg, Hesse, Germany
AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -
🇮🇹
Pesaro, PU, Italy
Kobe University Hospital
🇯🇵
Kobe-shi, Hyogo, Japan
Universitätsklinikum Köln
🇩🇪
Koeln, North Rhine Westphalia, Germany
Klinikum der Universitaet Muenchen
🇩🇪
Munich, Bavaria, Germany
Medizinische Hochschule Hannover
🇩🇪
Hannover, Germany
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek
🇭🇺
Debrecen, Hungary
AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia
🇮🇹
Torrette Di Ancona, Ancona, Italy
Azienda Ospedaliera Universitaria Senese.
🇮🇹
Siena, SI, Italy
Hemato-oncology ambulatory Service
🇮🇱
Petah Tikva, Israel
Gunma University Hospital
🇯🇵
Maebashi, Gunma, Japan
Japanese Red Cross Nagoya Daini Hospital
🇯🇵
Nagoya, Aichi, Japan
University of Fukui Hospital
🇯🇵
Yoshida-gun, Fukui, Japan
Gachon University Gil Medical Center
🇰🇷
Incheon, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷
Seoul, Korea, Republic of
National Hospital Organization Disaster Medical Center
🇯🇵
Tachikawa, Tokyo, Japan
Tohoku University Hospital
🇯🇵
Sendai, Miyagi, Japan
Hospital de la Santa Creu i Sant Pau
🇪🇸
Barcelona, Spain
Karolinska Universitetssjukhuset Huddinge
🇸🇪
Stockholm, Sweden
State Budgetary Healthcare Institution of Moscow
🇷🇺
Moscow, Russian Federation
Hospital del Mar
🇪🇸
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸
Madrid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸
Sevilla, Spain
Universitaetsklinikum Muenster
🇩🇪
Muenster, North Rhine-westphalia, Germany
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Tufts Medical Center Investigational Drug Pharmacy
🇺🇸
Boston, Massachusetts, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Centennial Medical Center
🇺🇸
Nashville, Tennessee, United States
TriStar Bone Marrow Transplant
🇺🇸
Nashville, Tennessee, United States
Blood Cancer and Stem Cell Transplant Clinic
🇺🇸
San Antonio, Texas, United States
Methodist Healthcare System of San Antonio
🇺🇸
San Antonio, Texas, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
Guangdong Provincial People's Hospital
🇨🇳
Guangzhou, Guangdong, China
Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi
🇮🇹
Bologna, Italy
Sunnybrook Research Institute
🇨🇦
Toronto, Ontario, Canada
CHU de Nantes Hotel Dieu
🇫🇷
Nantes cedex, France
Osaka City University Hospital
🇯🇵
Osaka-City, Osaka, Japan
Yokohama City University Medical Center
🇯🇵
Yokohama, Kanagawa, Japan
Shaare Zedek Medical Center
🇮🇱
Jerusalem, Israel
Somogy Megyei Kaposi Mor Oktato Korhaz
🇭🇺
Kaposvar, Hungary
UC Irvine Health - Chao Family Comprehensive Cancer Center
🇺🇸
Orange, California, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
UCLA Hematology/Oncology - Westlake Village
🇺🇸
Westlake Village, California, United States
Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU
🇦🇹
Salzburg, Austria
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Uniklinikum Salzburg, Landeskrankenhaus Salzburg
🇦🇹
Salzburg, Austria
St Vincent's Hospital Sydney
🇦🇺
Darlinghurst, New South Wales, Australia
Universitaire Ziekenhuizen Brussel (UZ Brussel)
🇧🇪
Brussels, Belgium
CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont
🇨🇦
Montreal, Quebec, Canada
CancerCare Manitoba
🇨🇦
Winnipeg, Manitoba, Canada
The First Affiliated Hospital of USTC, Anhui Provincial Hospital
🇨🇳
Hefei, Anhui, China
Fujian Medical University Union Hospital
🇨🇳
Fuzhou, Fujian, China
Anhui Provincial Hospital
🇨🇳
Hefei, Anhui, China
Saskatoon Cancer Centre
🇨🇦
Saskatoon, Saskatchewan, Canada
Henan Provincial People's Hospital/Hematology Department
🇨🇳
Zhengzhou, Henan, China
Guangdong Second Provincial General Hospital
🇨🇳
Guangzhou, Guangdong, China
Hebei Yanda Lu Daopei Hospital
🇨🇳
Langfang, Hebei, China
Henan Cancer Hospital
🇨🇳
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
🇨🇳
Wuhan, Hubei, China
The First Affiliated Hospital College of Medicine, Zhejiang University
🇨🇳
Hangzhou, Zhejiang, China
West China Hospital, Sichuan University
🇨🇳
Chengdu, Sichuan, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
🇨🇳
Tianjin, Tianjin, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳
Shanghai, China
Ustavni lekarna
🇨🇿
Ostrava - Poruba, Czechia
Nemocnicni lekarna
🇨🇿
Brno, Czechia
Klinika hematoonkologie
🇨🇿
Ostrava-Poruba, Czechia
Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady
🇨🇿
Praha 10, Czechia
CHU Henri Mondor
🇫🇷
Créteil, France
Centre Hospitalier Lyon Sud - Service d'Hematologie
🇫🇷
Pierre-Benite cedex, France
Hopital Saint Louis
🇫🇷
Paris, France
Institut Gustave Roussy
🇫🇷
Villejuif cedex, France
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪
Hamburg, Germany
Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály
🇭🇺
Győr, Hungary
Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz,
🇭🇺
Nyiregyhaza, Hungary
A.O.U. di Ferrara- Arcispedale Sant'Anna,
🇮🇹
Cona, Ferrara, FE, Italy
Rabin Medical Center, Beilinson Hospital
🇮🇱
Petah Tikva, Israel
Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia
🇭🇺
Nyiregyhaza, Hungary
SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
🇮🇹
Torette Di Ancona, AN, Italy
Azienda Ospedaliera Universitaria Senese
🇮🇹
Siena, Italy
Kindai University Hospital
🇯🇵
Osaka-Sayama, Osaka, Japan
Shizuoka Cancer Center
🇯🇵
Sunto-gun, Shizuoka, Japan
Akita University Hospital
🇯🇵
Akita, Japan
Tokyo Medical University Hospital
🇯🇵
Tokyo, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵
Kumamoto, Japan
Inje University Busan Paik Hospital
🇰🇷
Busan, Korea, Republic of
Chonbuk National University Hospital
🇰🇷
Jeonju-si, Jeollabuk-do, Korea, Republic of
Clinical Trial Center, Severance Hospital, Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
Instituto Nacional de Cancerología
🇲🇽
México, MÉX, Mexico
Severance Hospital, Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽
Monterrey, Nuevo LEON, Mexico
Spitalul Clinic Coltea, Clinica de Hematologie
🇷🇴
Bucuresti, Romania
Sp. Clinic de Urgenta Militar Central Dr. Carol Davila
🇷🇴
Bucharest, Romania
Hospital Universitario Arnau de Vilanova
🇪🇸
Lleida, Spain
State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH)
🇷🇺
Ryazan, Russian Federation
SBHI NNR NN RCH n. a. N.A. Semashko
🇷🇺
Nizhniy Novgorod, Russian Federation
Hospital Universitari i Politecnic La Fe
🇪🇸
Valencia, Spain
National Cheng Kung University Hospital
🇨🇳
Tainan, Taiwan
Hospital Universitario Ramon y Cajal
🇪🇸
Madrid, Spain
The Royal Marsden NHS Foundation Trust
🇬🇧
Sutton, Surrey, United Kingdom
National Taiwan University Hospital
🇨🇳
Taipei, Taiwan
MidAmerica Division, Inc., c/o Research Medical Center
🇺🇸
Kansas City, Missouri, United States
Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno
🇨🇿
Brno, Czechia
North Shore University Hospital
🇺🇸
Manhasset, New York, United States
Northwell Health/Monter Cancer Center
🇺🇸
Lake Success, New York, United States
OHSU Center for Health and Healing
🇺🇸
Portland, Oregon, United States
Long Island Jewish Medical Center
🇺🇸
New Hyde Park, New York, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
🇭🇺
Debrecen, Hungary
Imperial College Healthcare NHS Trust
🇬🇧
London, United Kingdom
Kyushu University Hospital
🇯🇵
Fukuoka, Japan
Swedish Cancer Institute
🇺🇸
Seattle, Washington, United States
St George Hospital
🇦🇺
Kogarah, New South Wales, Australia
Rambam Health Care Campus
🇮🇱
Haifa, Israel
Hadassah Medical Center (Ein Kerem)
🇮🇱
Jerusalem, Israel
Nagasaki University Hospital
🇯🇵
Nagasaki, Japan
V.A Almazov NMRC
🇷🇺
Saint Petersburg, Russian Federation
Keimyung University Dongsan Hospital
🇰🇷
Daegu, Korea, Republic of
Institutul Oncologic 'Prof. Dr. Ion Chiricuta'
🇷🇴
Cluj-Napoca, Cluj, Romania
Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie
🇷🇴
Craiova, Dolj, Romania
University Hospitals Birmingham NHS Foundation Trust
🇬🇧
Birmingham, WEST Midlands, United Kingdom
Royal University Hospital
🇨🇦
Saskatoon, Saskatchewan, Canada
Taipei Veterans General Hospital
🇨🇳
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳
Taipei, Taiwan

A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts