Actively Recruiting
Prospective Non-randomized Multicenter Trial of Chemotherapy Treatment in Children 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
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective non-randomized multicenter trial in Russia focused on children aged 0 to 18 years who have acute myeloid leukemia (AML) and Down syndrome (DS). The goal is to standardize current treatment approaches and build a national network for diagnosing, treating, and monitoring these patients. The study aims to improve long-term survival rates and reduce chemotherapy toxicity by lowering the dose of drugs used. The treatment plan includes four chemotherapy courses: Course 1 AIE (cytarabine, idarubicin, etoposide), Course 2 AI (cytarabine, idarubicin), Course 3 HAD (high-dose cytarabine with daunorubicin), and Course 4 HA (high-dose cytarabine). The protocol does not include maintenance therapy to help reduce side effects and improve quality of life. Safety is monitored using CTCAE version 5.0 criteria. Participants will be closely monitored through assessments including response rate, event-free survival, relapse-free survival, overall survival, treatment-related mortality, myelograms, and minimal residual disease (MRD) evaluations. Follow-up and safety monitoring will continue for up to two years to evaluate treatment effects and side effects. The study does not include maintenance therapy and involves collaboration among multiple centers in Russia.
CONDITIONS
Brief 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 to 18 years
- Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with Down syndrome (constitutional trisomy 21 and mutation in the GATA1 gene)
- Signed informed consent to participate
You will not qualify if you...
- Children with Down syndrome and acute lymphoblastic leukemia (ALL)
- Severe health conditions that prevent treatment according to the protocol
- More than 14 days of intensive induction therapy before enrollment
- Refusal to receive all or important parts of the therapy protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of four chemotherapy blocks as per protocol
Participants receive four chemotherapy blocks consisting of cytarabine, idarubicin, etoposide, daunorubicin, and high-dose cytarabine according to the study protocol to treat acute myeloid leukemia and Down syndrome.
Multiple visits for chemotherapy administration and monitoring
Duration - Up to 2 years
Participants are monitored for treatment response, survival outcomes, and safety for up to 2 years after treatment.
Periodic visits for up to 2 years
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
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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