St. Jude Children's Research Hospital
This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia. Primary Objective * To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231. * To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231. Secondary Objectives * To assess the event free and overall survival of patients treated with this therapy. * To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.
Patients will be identified in the first 3 days of therapy during their treatment on INITIALL. Treatment will consist of 3 main phases: Induction, Early Post Induction \[including Consolidation, High-Dose Methotrexate, Intensification, Interim 1, Reinduction 1, Interim 2, and Reinduction 2\], and Maintenance. Induction: * Remission Induction includes 3 days of therapy on the INITIALL classification protocol as well as the remainder of a total of 4 weeks of induction treatment on this trial. Treatment includes a total of 28 days of dexamethasone, 4 weekly doses of vincristine, 3 doses of dau…
Inclusion Criteria: * Enrollment on INITIALL. * Age 1-18.99 years at the time of enrollment on INITIALL. * T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia/ lymphoma * No prior chemotherapy excluding therapy given on or allowed by INITIALL. * Patient has completed no more than 3 days of chemotherapy on INITIALL. * Direct bilirubin ≤ 1.5x the upper limit of normal for age * Alanine aminotransferase (ALT) ≤ 5x the upper limit of normal for age * Calculated glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m\^2 using the Bedside Schwartz equation OR creat…
Given orally (PO) or intravenously (IV).
Given IV.
Given IV.
Given IV.
Given PO
Given PO (ETP, near-ETP, and MPAL only).
Given IV (T-LLy only).
Given Intrathecal (IT), Age adjusted.
Given IV.
Given IV or IT.
Given PO.
Given IV
Given IT, IV, PO or intramuscular (IM).
Given PO (participants intolerant to mercaptopurine).