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

RecruitingPhase 3Ages 1 Day - 18 YearsAllFederal Research Institute of Pediatric Hematolog…
NCT07232134 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • 4 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).
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Where

1 site
National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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