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

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT04968015
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cytarabine-Venetoclax Association — DRUG
    Consolidation treatment with cytarabine + venetoclax
  • Cytarabine-Idarubicin Association — DRUG
    Consolidation treatment with cytarabine + idarubicin

Study Details

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.

Key Dates

Start date
May 25, 2022
Status verified
Jun 2024
Primary completion
Aug 15, 2025
Completion
Jan 31, 2029

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VEN-CYTA
    Venetoclax 600mg/day, Per Os (PO), D1 to D14 / 28 days cycle Cytarabine 50 mg/m2/12h Subcutaneous (SC), D1 to D5 / 28 days cycle
  • Active Comparator: IDA-CYTA
    Idarubicin 8mg/m2, Intravenous (IV), at D1 / 28 days cycle Cytarabine 50 mg/m2/12h, SC, D1 to D5 / 28 days cycle

Primary Outcome Measure

Relapse Free Survival (RFS) [ Time Frame: from randomization to last follow-up (up to 5 years) ]

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