Clinical Trial

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2024-04-25; most recent amendment 2026-07-15.
Status change: Not Yet Recruiting → Recruiting 2025-01-10
Trial Details
NCT Number NCT06390319
Lead Sponsor St. Jude Children's Research Hospital
Collaborators: AbbVie
Conditions T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoma, Mixed Phenotype Acute Leukemia
Enrollment 100 participants
Start Date 2024-12-27
Primary Completion 2027-12 (estimated)
Study Completion 2033-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-10