RecruitingNot ApplicableNCT07243483

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

Prospective, Multicenter, Clinical-biological Cohort Study to Assess Pharmacokinetics and Pharmacodynamics (PK-PD) of Venetoclax (VEN) in Patients With Acute Myeloid Leukemia (AML)

Sponsor

Centre Leon Berard

Enrollment

100 participants

Start Date

Jan 21, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

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 maximum of 12 mL of blood per sampling day (4 mL at each sampling time) for PK dosing of venetoclax.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how the body processes venetoclax — a targeted cancer drug — in patients with acute myeloid leukemia (AML, a type of blood cancer), and how the drug's levels in the blood relate to its effects on the cancer and on healthy blood cells. This helps researchers figure out the best dosing approach. **You may be eligible if...** - You are 18 years or older with a confirmed AML diagnosis (classified per ELN 2022 criteria) - You are about to begin treatment with venetoclax combined with azacitidine as your first line of treatment - You are registered with a social security system - You can understand and sign the informed consent form **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL) - You are eligible for intensive chemotherapy - You have previously been treated with venetoclax or azacitidine - You are already enrolled in another clinical trial with an investigational drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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