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

Recruiting now · Phase 3

Conditions studied: AML (Acute Myelogenous Leukemia), Down Syndrome (DS)

In brief

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

Key facts

Study ID

NCT07232134

Run by

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

People needed

100

Starts

2025-07-24

Expected to finish

2032-12-30

Last updated by the study team

2025-11-20

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Children with Down syndrome and acute lymphoblastic leukemia (ALL)
• Severe comorbidities with contraindications to the treatment according to the protocol
• Pre-treatment >14 days with intensive induction therapy
• Refusal of all therapy or important elements of therapy

Where it is running

• National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198 — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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