Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)

Sponsor
University Hospital, Caen
Study ID
NCT06045819
Status
Recruiting
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Conditions

  • Adult Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
60 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy was not an option. Over and above the clinical benefits of this combination, the data show that more than half the patients did not show remission criteria, even after the first month's exposure to venetoclax. Hypothesis: To compare the mean residual venetoclax plasma concentrations obtained in patients who went into complete composite remission versus those who did not go into remission at the end of the first cycle of venetoclax + azacitidine treatment. Method: According to the French law, this is a multicenter, non-comparative, open-label, single-arm, interventional study with minimal risks and constraints. Selection, information and inclusion will concern adult patients (≥60 years) with a confirmed diagnosis of AML according to ELN 2022 guidelines. Included patients will be treated as standard care with a combination of venetoclax+azacitidine. This research protocol will not modify their usual care.

Key Dates

Start date
Apr 8, 2024
Status verified
Feb 2025
Primary completion
Feb 28, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Patients with composite complete remission
    Patients in composite complete remission following the first cycle of venetoclax (400 mg/day, orally, after a ramp-up phase of the first 3 days) + azacytidine (75mg/m²,intravenous, at the start of each cycle from day 1 to day 7)
  • Arm: Patients without composite complete remission
    Patients not in composite complete remission following the first cycle of venetoclax (400 mg/day, orally, after a ramp-up phase of the first 3 days) + azacytidine (75mg/m²,intravenous, at the start of each cycle from day 1 to day 7)

Primary Outcome Measure

Comparison of mean plasma residual concentration of venetoclax [ Time Frame: 1 month ]

Central Contacts

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