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)

• Status: RECRUITING
• Trial end date: 2033-12-01

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.

• Phase: PHASE2

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: AbbVie
• Treatments: Bortezomib; calaspargase pegol; Calcium Dobesilate; Cyclophosphamide; Cytarabine; Dasatinib; Daunorubicin; Dexamethasone; Hydrocortisone; Mercaptopurine; Methotrexate; nelarabine; Thioguanine; venetoclax; Vincristine