Study of Chemotherapy Treatment Effectiveness in Children with Acute Myeloid Leukemia and Down Syndrome in Russia A Multicenter Trial Using Four Chemotherapy Blocks to Improve Survival and Reduce Toxicity

What this Trial Is About

Researchers are conducting a prospective non-randomized multicenter trial in Russia focused on children aged 0 to 18 years who have acute myeloid leukemia AML and Down syndrome DS. The goal is to standardize current treatment approaches and build a national network for diagnosing, treating, and monitoring these patients. The study aims to improve long-term survival rates and reduce chemotherapy toxicity by lowering the dose of drugs used. The treatment plan includes four chemotherapy courses Course 1 AIE cytarabine, idarubicin, etoposide, Course 2 AI cytarabine, idarubicin, Course 3 HAD high-dose cytarabine with daunorubicin, and Course 4 HA high-dose cytarabine. The protocol does not include maintenance therapy to help reduce side effects and improve quality of life. Safety is monitored using CTCAE version 5.0 criteria. Participants will be closely monitored through assessments including response rate, event-free survival, relapse-free survival, overall survival, treatment-related mortality, myelograms, and minimal residual disease MRD evaluations. Follow-up and safety monitoring will continue for up to two years to evaluate treatment effects and side effects. The study does not include maintenance therapy and involves collaboration among multiple centers in Russia.

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