Clinical Trial

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

Study acronym: LAMSA2020

Active, Not Recruiting Phase 2

Record status

This record was last updated June 27, 2024 (before its estimated August 15, 2025 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 6 amendments

This ClinicalTrials.gov record has been amended 6 times since 2021-07-13; most recent amendment 2024-06-26.

Status change: Recruiting → Active, Not Recruiting 2024-06-26

Status change: Not Yet Recruiting → Recruiting 2022-07-26

Trial Details

NCT Number	NCT04968015
Lead Sponsor	French Innovative Leukemia Organisation
Conditions	Acute Myeloid Leukemia
Enrollment	134 participants
Start Date	2022-05-25
Primary Completion	2025-08-15 (estimated)
Study Completion	2029-01-31 (estimated)
Updated on ClinicalTrials.gov	2024-06-27