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Recruiting NCT07243483

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

No phase Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacokinetic dosages of venetoclax.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Pharmacokinetic dosages of venetoclax
    Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period

Primary outcome measures

  • Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint [Time frame: From the first day of venetoclax administration to end of the treatment (days)]
  • Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint [Time frame: From the first day of venetoclax administration to end of the treatment (days)]
  • Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint [Time frame: From the first day of venetoclax administration to end of the treatment (days)]
  • Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint [Time frame: From the first day of venetoclax administration to end of the treatment (days)]
  • Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Clinical Endpoint [Time frame: From the first day of venetoclax administration up to day 28 (end of the first venetoclax cure)]
Secondary outcome measures (3)
  • To assess relationship between different PK markers of venetoclax and its clinical efficacy. [Time frame: From the first day of venetoclax administration and through study completion, at least 24 months]
  • To assess correlation between plasmatic exposition to venetoclax and occurrence of adverse events [Time frame: From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration]
  • To assess inter-individual and intra-individual variability in plasma exposure to venetoclax. [Time frame: From the first day of ventoclax administration and nd through study completion, at least 24 months]

Eligibility criteria

Inclusion 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.
  • Patient must be affiliated or benificiary of a social security system.

Exclusion criteria

  • Patient with acute promyelocytic leukemia (APL, AML3)
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 5 centers
  • Centre Hospitalier Pierre Oudot — Bourgoin
  • CHU de Grenoble — Grenoble
  • Centre Leon Berard — Lyon
  • CHU de Saint-Étienne — Saint-Etienne
  • Hôpitaux Nord-Ouest - Villefranche-sur-Saône — Villefranche-sur-Saône

Identifiers

NCT: NCT07243483 · ET24-223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗