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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
850
Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
Intravenously (IV) for 1 dose on Day 1 or 2
Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
Given IT as part of Intrathecal triple therapy.
Given IT as part of Intrathecal triple therapy.
Rady Children's Hospital
San Diego, California, United States
RECRUITINGSaint Francis Children's Hospital
Tulsa, Oklahoma, United States
RECRUITINGSt. Jude Children's Research Hospital
Memphis, Tennessee, United States
RECRUITINGSufficient 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.
Time frame: 1 week from study entry
Complete data within the INITIALL database
The proportion of patients with complete data within the INITIALL protocol database as described in the protocol.
Time frame: 3 months, 1 year, 3, 5 years from study entry
Event Free Survival (EFS)
EFS will be reported as estimates using the Kaplan-Meier method.
Time frame: 1, 3, 5 years from study entry
Overall Survival (OS)
OS will be reported as estimates using the Kaplan-Meier method.
Time frame: 1, 3, 5 years from study entry
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