NCT07232134RecruitingPhase 3
The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
Prospective Non-randomized Multicenter Trial: the Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 24 Jul 2025
- Primary completion date
- 24 Jul 2030
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07232134
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 24 Jul 2025 to the primary completion date, 24 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-treatment \>14 days with intensive induction therapy
- Refusal of all therapy or important elements of therapy
Other illness
- Children with Down syndrome and acute lymphoblastic leukemia (ALL)
Other
- Severe comorbidities with contraindications to the treatment according to the protocol
Who the study is looking for
- 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
Age in the registry: 1 day to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198 Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.