Overview

Prospective Non-randomized Multicenter Trial: the Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia

Status:
RECRUITING

Trial end date:
2032-12-30

Target enrollment:

Participant gender:

Summary

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 we 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

Phase:

PHASE3

Details

Lead Sponsor:

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Treatments:

Cytarabine
Daunorubicin
Etoposide
Idarubicin