Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
- Conditions
- Lymphoblastic LymphomaMixed Phenotype Acute LeukemiaAcute Lymphoblastic Leukemia
- Interventions
- Registration Number
- NCT06289673
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief Summary
The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.
Primary Objectives
* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.
* To develop a central database of genomic and clinical findings.
Secondary Objectives
* To assess event free and overall survival data of patients enrolled on this study.
- Detailed Description
Patients with newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL/LLy) and mixed phenotype acute leukemia/lymphoma (MPAL) will undergo diagnostic procedures either during screening or on Day 1. They will receive 7 days of chemotherapy including 13 doses of dexamethasone, 1 dose of vincristine, and 1 dose of daunorubicin (for patients with T-ALL/LLy or MPAL only). Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy. After the completion of 7 days of chemotherapy, patients will begin therapy on either a SJALL therapeutic trial or will receive non-protocol therapy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 850
-
Age 1-18.99 years
-
Diagnosis of acute leukemia / lymphoma as below:
- Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample).
- Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and <25% bone marrow blasts and less than 1,000 circulating blasts/ microL.
- Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible).
- Pregnant or breastfeeding
- Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy.
- Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.).
Note: The intention of this exclusion criterion is to enroll all newly diagnosed ALL/ LLy/ MPAL patients. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Newly diagnosed ALL, LLy, and MPAL patients Dexamethasone All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) Newly diagnosed ALL, LLy, and MPAL patients Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) Newly diagnosed ALL, LLy, and MPAL patients Vincristine All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) Newly diagnosed ALL, LLy, and MPAL patients Daunorubicin All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) Newly diagnosed ALL, LLy, and MPAL patients Methotrexate All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) Newly diagnosed ALL, LLy, and MPAL patients Cytarabine All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
- Primary Outcome Measures
Name Time Method Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy). 1 week from study entry The proportion of patients with sufficient immunophenotypic, genomic, and clinical data to allow determination of eligibility for currently open trials at the enrolling institution.
Complete data within the INITIALL database 3 months, 1 year, 3, 5 years from study entry The proportion of patients with complete data within the INITIALL protocol database as described in the protocol.
- Secondary Outcome Measures
Name Time Method Event Free Survival (EFS) 1, 3, 5 years from study entry EFS will be reported as estimates using the Kaplan-Meier method.
Overall Survival (OS) 1, 3, 5 years from study entry OS will be reported as estimates using the Kaplan-Meier method.
Trial Locations
- Locations (1)
United States, Tennessee St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States