Actively Recruiting
Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia
Led by Centre Leon Berard · Updated on 2026-05-08
100
Participants Needed
5
Research Sites
153 weeks
Total Duration
On this page
Sponsors
C
Centre Leon Berard
Lead Sponsor
F
Fédération Leucémie Espoir
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient aged of at least 18 years on day of signing informed consent
- Patient with histologically-confirmed diagnosis of Acute Myeloblastic Leukaemia according to classification ELN 2022
- Patient who has to initiate treatment venetoclax-azacitidine as first line (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
- Patient must be affiliated or beneficiary of a social security system
You will not qualify if you...
- Patient with acute promyelocytic leukemia (APL, AML3)
- Patient with AML eligible to intensive chemotherapy
- Patient previously treated with venetoclax and/or azacitidine
- Patient participating in 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 could prevent informed consent or interfere with study compliance
- Patient under curatorship, guardianship, or judicial protection
- Pregnant or breast-feeding female patient
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Trial Site Locations
Total: 5 locations
1
Centre Hospitalier Pierre Oudot
Bourgoin, France, France
Actively Recruiting
2
CHU de Grenoble
Grenoble, France, 38000
Actively Recruiting
3
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
4
CHU de Saint-Étienne
Saint-Etienne, France, 42100
Actively Recruiting
5
Hôpitaux Nord-Ouest - Villefranche-sur-Saône
Villefranche-sur-Saône, France, 69400
Actively Recruiting
Research Team
M
Michaël Philippe
CONTACT
A
Amine Belhabri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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