Actively Recruiting
The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2025-11-20
100
Participants Needed
1
Research Sites
388 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0-18 years
- Diagnosis of AML or MDS with Down syndrome (constitutional trisomy 21 and mutation in the GATA1 gene)
- Signed informed consent
You will not qualify if you...
- Children with Down syndrome and acute lymphoblastic leukemia (ALL)
- Severe comorbidities contraindicating treatment according to the protocol
- More than 14 days of prior intensive induction therapy
- Refusal of all or important parts of therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198
Moscow, Russia
Actively Recruiting
Research Team
Z
Zalina A Abashidze, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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