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

Study acronym: AML-DS-2025
StatusRecruiting
PhasePhase 3
Started2025-07-24
View on ClinicalTrials.gov ↗

Amendment history

2025-11-17
Study Identification, Study Status, Study Description v1
Study description+13 characters
[...] with AML and Down syndrome in Russia. Based on the results wethe investigators expect to increasingincrease long-term overall and event-free survival in children with [...]
Study title-46 characters
Prospective Non-randomized Multicenter Trial: theThe Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
2025-11-14
Original filing
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
Trial Details
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