Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia
NCT ID: NCT07243483
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2026-01-01
2029-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line
Blood samples
Pharmacokinetic dosages of venetoclax
Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period
Interventions
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Pharmacokinetic dosages of venetoclax
Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Fédération Leucémie Espoir
UNKNOWN
Centre Leon Berard
OTHER
Responsible Party
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Locations
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Centre Leon Berard
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ET24-223
Identifier Type: -
Identifier Source: org_study_id
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