Study of New Drug Combinations for Treating Children and Teens with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia Using Dasatinib, Venetoclax, and Homoharringtonine to Improve Treatment Outcomes

What this Trial Is About

Researchers are evaluating whether adding three new drugsdasatinib, venetoclax, and homoharringtonineto current treatment can improve outcomes for children newly diagnosed with T-cell acute lymphoblastic leukemia T-ALL. This study is conducted across multiple centers within the Chinese Childrens Cancer Group and focuses on increasing remission rates, enhancing event-free survival, and lowering relapse rates. The treatment plan varies by patient subgroup. All children receive dexamethasone during induction therapy. For patients with early T-cell precursor ETP or near-ETP T-ALL, venetoclax replaces daunorubicin in induction and interim therapies, with changes to chemotherapy regimens to reduce fertility impact. Non-ETP patients receive dasatinib after an initial phase, with some randomized to different doses of homoharringtonine during intensification and reinduction therapies. Maintenance therapy includes adjusted chemotherapy cycles to lessen long-term effects. Participants undergo regular assessments including bone marrow tests to measure minimal residual disease MRD and monitor response to treatment. Researchers track remission rates, event-free survival, relapse incidence, and treatment side effects over approximately 5 to 6.5 years. Drug sensitivity testing is also added to help guide treatment choices. Safety is closely monitored during and after treatment to assess adverse events and overall outcomes.

Newly-diagnosed Pediatric T-cell ALL Protocol