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.
Age 1-18.99 years
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.).
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Single group
Dexamethasone
DrugPer mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
Vincristine
DrugIntravenously (IV) for 1 dose on Day 1 or 2
Daunorubicin
DrugIntravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
DrugIntrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
Methotrexate
DrugGiven IT as part of Intrathecal triple therapy.
Cytarabine
DrugGiven IT as part of Intrathecal triple therapy.
Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy).
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
The proportion of patients with complete data within the INITIALL protocol database as described in the protocol.
Event Free Survival (EFS)
EFS will be reported as estimates using the Kaplan-Meier method.
Overall Survival (OS)
OS will be reported as estimates using the Kaplan-Meier method.
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