NCT07243483Recruiting
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)
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 2 Oct 2025
- Start date
- 21 Jan 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Centre Leon Berard
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07243483
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 21 Jan 2026 to the primary completion date, 1 Jan 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with AML eligible to intensive chemotherapy
- Patient previously treaed with venetoclax and/or azacitidine
Other illness
- Any condition that contraindicates blood sampling procedures required by the protocol
Other
- Patient with acute promyelocytic leukemia (APL, AML3)
- Patient participating to another clinical trial with a medicinal product
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Pierre Oudot Coordinator of this site? Confirm its status | Bourgoin | France | Recruiting |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
| Hôpitaux Nord-Ouest - Villefranche-sur-Saône Coordinator of this site? Confirm its status | Villefranche-sur-Saône | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.