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Recruiting Phase 3

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

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About this study

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

Condition
AML (Acute Myelogenous Leukemia), Down Syndrome (DS)
Tested
4 chemotherapy blocks: Course 1 AIE (cytarabine/idarubicin/etoposide), Course 2 AI (cytarabine/idarubicin), Course 3 HAD...
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Who can join

Age
0 to 18 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 0 years
  • Maximum age: 18 years
  • Study condition: AML (Acute Myelogenous Leukemia), Down Syndrome (DS)
  • 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 4

  • 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

Where

1 site, 1 recruiting

National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198

Moscow, Russia

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.