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NCT Number: NCT07243483

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Pierre Oudot, Bourgoin, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacokinetic dosages of venetoclax

Other

Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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).

  2. 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

  3. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amine Belhabri, MD

CONTACT

[email protected]

Michaël Philippe

CONTACT

[email protected]

+33478782666

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Fédération Leucémie Espoir

Registry information

Official study title

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

Acronym: EUREKA-VEN

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Nov 24, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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