Pediatric Treatment of Very High-Risk Acute Lymphoblastic Leukemia Using Dasatinib and Other Therapies in Korea

What this Trial Is About

This research focuses on pediatric patients with very high-risk acute lymphoblastic leukemia ALL, including those with Philadelphia chromosome-positive disease or other poor prognosis markers. It aims to evaluate treatment approaches involving Dasatinib and other therapies in children aged 1 to 19 years. The study is a Phase 2 interventional trial conducted in Korea, investigating strategies to improve outcomes in these high-risk cases. Participants are assigned to one of two treatment groups based on their leukemia subtype. Arm A includes patients with Philadelphia chromosome-positive ALL receiving induction therapy mainly with Dasatinib, followed by multiple consolidation phases, delayed intensification, interim maintenance, and maintenance therapy, with adjustments based on minimal residual disease MRD and qPCR test results. Arm B involves other very high-risk ALL patients receiving induction, consolidation phases, and possible hematopoietic stem cell transplantation HSCT, with therapy tailored by MRD status. Treatments include drugs such as Blinatumomab, high-dose methotrexate, and cytarabine, with some patients undergoing allogeneic HSCT. Throughout the study, participants undergo repeated assessments of leukemia status using MRD and qPCR tests after induction and consolidation phases to guide treatment decisions. Researchers monitor event-free survival up to five years as the primary outcome, alongside overall survival, relapse rates, adverse events, transplantation rates, and treatment-related mortality. Safety is closely followed from treatment start through 28 days after the last drug dose. The study duration extends up to five years, allowing long-term evaluation of treatment effectiveness and safety in this pediatric population.

Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea