Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia

This is a prospective, multicenter, clinical-biological cohort study. Its objective is to assess the pharmacokinetics-pharmacodynamics (PK-PD) of venetoclax (VEN) in patients with Acute Myeloid Leukemia (AML). This study involves only minimal risks and constraints related to the collection of biological samples (blood samples for PK testing) and the collection of clinical data. Therapeutic management of patients participating in this study is not changed. A total of 100 patients will be included in the study over a 12-month period. A maximum of 21 additional samples are planned, with a maximu

Trial Details

NCT ID
NCT07243483
Phase
NA
Sponsor
Centre Leon Berard
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Pharmacokinetic dosages of venetoclax
Locations (sample)
  • Bourgoin, France, France|45.59889,5.27236
  • Grenoble, France|45.17869,5.71479
  • Lyon, France|45.74906,4.84789
  • Saint-Etienne, France|45.43389,4.39
  • Villefranche-sur-Saône, France|45.98967,4.71961

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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