Therapy plan for children with Down syndrome and acute myeloid leukemia in Russia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized, multicenter Phase 3 program based on the ML DS 2006 protocol designed to standardize diagnosis, treatment, and monitoring of children with AML and Down syndrome across Russia. All enrolled patients receive four chemotherapy blocks (Course 1 AIE: cytarabine/idarubicin/etoposide; Course 2 AI: cytarabine/idarubicin; Course 3 HAD: high-dose cytarabine (1 g)/daunorubicin; Course 4 HA: high-dose cytarabine) with safety monitored using CTCAE v5.0. Eligible patients are children aged 0–18 with constitutional trisomy 21 and a GATA1 mutation; transient abnormal myelopoiesis (TAM) cases may be enrolled but analyzed separately. The program aims to create a national network to harmonize care and reduce cumulative chemotherapy doses where safe.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Zalina A Abashidze, MD
• Email: zalina.abashidze@dgoi.ru
• Phone: 89661101770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.