Tests chemotherapy in children with acute myeloid leukemia and Down syndrome
Tests 4 chemotherapy courses in children with leukemia and Down syndrome.
Plain-language title generated from the registry record
Registry title: The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
Key facts
- Where
- Moscow, RussiaSee the site
- Phase
- Phase 3
Where in Russia
- National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198Moscow, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Trial code
- NCT07232134
- Record updated
- 20 November 2025
- Original description
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.Read full original descriptionShow less
Prospective Non-randomized Multicenter Trial: 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
Inclusion: Age 0-18 years; Diagnosis of AML, MDS and presence of Down syndrome (constitutional trisomy 21 and mutation in the GATA1 gene); Signed informed consent.
Exclusion: Pre-treatment >14 days with intensive induction therapy; Refusal of all therapy or important elements of therapy; Children with Down syndrome and acute lymphoblastic leukemia (ALL); Severe comorbidities with contraindications to the treatment according to the protocol.