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.
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.
Inability or unwillingness to give informed consent/ assent as applicable.
Patients with > Grade 2 neuropathy at the time of enrollment (participant with T-LLy only).
Documented malabsorption syndrome or any other condition that precludes receipt of oral medications.
Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).
St. Jude Children's Research Hospital
Lead sponsor
AbbVie
Collaborator