The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia

This prospective non-randomized multicenter trial created based on protocol ML DS 2006 and aimed at standardization of current therapy approaches and creating a national network for diagnostic, treatment and monitoring of children (0-18 years) with AML and Down syndrome in Russia. Based on the results the investigators expect to increase long-term overall and event-free survival in children with AML and DS and reduce the immediate and remote toxicity of chemotherapy by reducing the dose load of chemotherapeutic drugs. The study protocol therapy for all patients includes four chemotherapy blocks: Course 1 AIE (cytarabine/idarubicin/etoposide) Course 2 AI (cytarabine/idarubicin) Course 3 HAD (high -dose cytarabine (1g)/daunorubicin) Course 4 HA (high-dose cytarabine) Safety to be monitored based on CTCAE v5.0

NCT Number	NCT07232134
Lead Sponsor	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions	AML (Acute Myelogenous Leukemia), Down Syndrome (DS)
Enrollment	100 participants
Start Date	2025-07-24
Primary Completion	2030-07-24 (estimated)
Study Completion	2032-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-20