The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
Recruiting
Phase 3
Interventional Study
AML (Acute Myelogenous Leukemia)
Down Syndrome (DS)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Day – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Other
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About This Trial
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 A…
Trial Locations
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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 cont…
Contacts