Improving Treatment for Children and Teens With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia, Lymphoma, or Mixed Phenotype Acute Leukemia by Adding Dasatinib or Venetoclax

What this Trial Is About

Researchers are evaluating whether adding one of two chemotherapy drugs, dasatinib or venetoclax, can improve treatment outcomes for children and young adults newly diagnosed with T-cell acute lymphoblastic leukemia T-ALL, T-cell lymphoma, or mixed phenotype acute leukemia MPAL. This Phase 2 clinical trial aims to assess if these drugs can increase the rate of negative minimal residual disease MRD at the end of induction compared to previous treatments. Secondary goals include assessing survival rates and comparing treatment toxicities. Treatment for participants includes three main phases Induction, Early Post Induction, and Maintenance, lasting approximately two and a quarter years. Induction involves standard chemotherapy drugs plus an additional agent based on leukemia typedasatinib for T-ALL, venetoclax for ETP or near-ETP ALL and MPAL, and bortezomib for T-lymphoma. Early Post Induction consists of several cycles of chemotherapy, including consolidation, high-dose methotrexate, intensification, interim therapies, and reinduction phases. Maintenance therapy follows with a combination of oral and intravenous chemotherapy over many weeks, monitored by regular intrathecal treatments. Participants will be closely monitored throughout the study with treatment administered orally or intravenously as appropriate. Researchers will measure MRD negativity at the end of induction and track event-free and overall survival for up to ten years. Safety monitoring includes observing grade 4 toxicities during treatment. Follow-up visits are recommended every few months initially, then annually for up to ten years to assess long-term remission and patient health.

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)