OncoMatch/Clinical Trials/NCT07232134
The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia
Is NCT07232134 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies 4 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). for aml (acute myelogenous leukemia).
Treatment: 4 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). — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: GATA1 mutation
Demographics
Prior therapy
Cannot have received: intensive induction therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07232134 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior intensive induction therapy disqualifies patients from enrollment.
Does this trial require GATA1?
Yes, GATA1 mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages