drugset / Trial / NCT04968015

Venetoclax + Cytarabine Versus Idarubicin + Cytarabine : Efficacity Assessment as Post-remission Therapy to Elderly Patients With Acute Myeloid Leukemia in First Remission

NCT04968015

Phase 2 Active not recruiting 134 enrolled French Innovative Leukemia Organisation
RandomizedParallel-groupOpen-labelTreatment

Summary

For the FILO group, the standard of care for induction chemotherapy of elderly fit patients with AML is represented by the combination of Cytarabine, Idarubicin and Lomustine. The superiority of this combination was confirmed in a larger prospective study the LAMSA-2007. This induction treatment, followed by six courses of consolidation (Idarubicin and Cytarabine) followed then by a period of 6-month maintenance therapy, allows up to 80 % of remission, and a RFS of 46 % at 2 years. The aim of the study is to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first complete remission (CR) following induction chemotherapy.

Timeline

Start
2022-05-25
Primary completion
2025-08-15
Completion
2029-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Idarubicin Small molecule 8 mg/m2 Intravenous
Subject Venetoclax Small molecule 600 mg Oral
Comparator Cytarabine Small molecule 50 mg/m2 Subcutaneous