How venetoclax blood levels relate to treatment response in acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter clinical-biological cohort that will follow 100 adult patients with AML over a 12-month inclusion period while they receive standard venetoclax‑azacitidine therapy. The study will collect serial blood samples (up to 21 additional samplings, maximum 12 mL per sampling day) to measure venetoclax pharmacokinetics and link those levels to pharmacodynamic measures and cytologic response. Therapeutic management is not altered by participation and the protocol excludes patients previously treated with venetoclax or azacitidine, those eligible for intensive chemotherapy, and patients with acute promyelocytic leukemia. The design focuses on real-world treatment settings at several French centers to clarify how drug levels and interactions (for example with azole antifungals) affect outcomes and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female patient aged of at least 18 years on day of signing informed consent
* Patient with histologically-confirmed diagnosis of Acute Myeloblactic Leukaemia according to classification ELN 2022 (European Leukemia Net 2022)
* Patient who has to initiate treatment venetoclax-azacitidine as first line. Note : triple associations with targeted therapy are not authorized
* Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.
* Patient must be affiliated or benificiary of a social security system.

Exclusion Criteria:

* Patient with acute promyelocytic leukemia (APL, AML3)
* Patient with AML eligible to intensive chemotherapy
* Patient previously treaed with venetoclax and/or azacitidine
* Patient participating to another clinical trial with a medicinal product
* Any condition that contraindicates blood sampling procedures required by the protocol
* Any psychological, family, geographical, or social situation that, according to investigator's judgment, could potentially prevent the signing of an informed consent form and/or woulld likely interfere compliance with study procedures.
* Patient under curatorship, guardianship or judicial protection
* Pregnant or breast-feeding female patient.

Where it's running

• Centre Hospitalier Pierre Oudot
  Bourgoin, France, France Recruiting
• CHU de Grenoble
  Grenoble, France Recruiting
• Centre Leon Berard
  Lyon, France Recruiting
• CHU de Saint-Étienne
  Saint-Etienne, France Recruiting
• Hôpitaux Nord-Ouest - Villefranche-sur-Saône
  Villefranche-sur-Saône, France Recruiting

Study contacts

• Study coordinator: Michaël Philippe
• Email: michael.philippe@lyon.unicancer.fr
• Phone: +33478782666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.