NCT07232134 The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
| NCT ID | NCT07232134 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
| Condition | AML (Acute Myelogenous Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-24 |
| Primary Completion | 2030-07-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2025-07-24 with a primary completion date of 2030-07-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07232134 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 18 Years, studying AML (Acute Myelogenous Leukemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07232134 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT07232134 currently recruiting?
Yes, NCT07232134 is actively recruiting participants. Contact the research team at zalina.abashidze@dgoi.ru for enrollment information.
Where is the NCT07232134 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07232134 clinical trial?
NCT07232134 is sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. The trial plans to enroll 100 participants.
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