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

May 7, 2026 updated by: Centre Leon Berard

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38000
        • Recruiting
        • Chu de Grenoble
        • Contact:
      • Lyon, France, 69008
      • Saint-Etienne, France, 42100
      • Villefranche-sur-Saône, France, 69400
        • Recruiting
        • Hôpitaux Nord-Ouest - Villefranche-sur-Saône
        • Contact:
          • Sylvain LAMURE, Dr
          • Phone Number: +33 4 74 69 87 46
          • Email: slamure@hno.fr
    • France
      • Bourgoin, France, France
        • Recruiting
        • Centre Hospitalier Pierre Oudot
        • Contact:
        • Principal Investigator:
          • Clément Rocher, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line
Blood samples
Other: Pharmacokinetic dosages of venetoclax
Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
To assess PK exposure parameters : AUC (area under the curve) of venetoclax at steady state
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)
To assess PK exposure parameters : Minimal Concentration (Cmin) of venetoclax at steady state
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)
To assess PK exposure parameters : Peak Plasma Concentration (Cmax) of venetoclax at steady state
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)
To assess PK exposure parameters : Equilibrium concentration (Css) of venetoclax at steady state
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)
Proportion of patients with a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) or partial remission (PR) or no remission
From the first day of venetoclax administration up to day 28 (end of the first venetoclax cure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Correlation between PK exposure parameters (including Cmin, Cmax, Css) of venetoclax and clinical outcome (cytologic response at cycle 6, survival without progression and overall survival).
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
Correlation between PK exposure parameters (including Cmin, Cmax, Css) of venetoclax and occurence of adverse events grade equal or superior to 3 related to venetoclax/azacitidine and their impact on treatment administration
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
Coefficient of variation of AUC and Cmin at steady state for venetoclax
From the first day of ventoclax administration and nd through study completion, at least 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the relationship between plasmatic venetoclax exposition and response to treatment
Time Frame: From the first day of venetoclax administration to through the study, at least 24 months
To assess correlation between minimal concentration of venetoclax and minimal residual disease
From the first day of venetoclax administration to through the study, at least 24 months
To assess the relationship between plasmatic venetoclax exposition and response to treatment
Time Frame: From the first day of venetoclax administration to through the study, at least 24 months
To assess correlation between Peak Plasma Concentration (Cmax) of venetoclax and minimal residual disease
From the first day of venetoclax administration to through the study, at least 24 months
To assess the relationship between plasmatic venetoclax exposition and response to treatment
Time Frame: From the first day of venetoclax administration to through the study, at least 24 months
To assess correlation between Equilibrium concentration of venetoclax (Css) and minimal residual disease
From the first day of venetoclax administration to through the study, at least 24 months
To assess interaction between azole antifungals and venetoclax
Time Frame: From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration
Number of patients treated or not treated by an azole antifungal
From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

Fédération Leucémie Espoir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

October 2, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET24-223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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