NCT07243483

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

October 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

October 2, 2025

Last Update Submit

March 3, 2026

Conditions

Acute Myeloid Leukemia

Keywords

PharmacokineticsVenetoclaxPharmacodynamicsCytologic responseAzole antifungal

Outcome Measures

Primary Outcomes (5)

  • Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint

    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

    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

    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

    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

    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 Outcomes (3)

  • To assess relationship between different PK markers of venetoclax and its clinical efficacy.

    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

    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.

    From the first day of ventoclax administration and nd through study completion, at least 24 months

Other Outcomes (4)

  • To assess the relationship between plasmatic venetoclax exposition and response to treatment

    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

    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

    From the first day of venetoclax administration to through the study, at least 24 months

  • +1 more other outcomes

Study Arms (1)

Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line

EXPERIMENTAL

Blood samples

Other: Pharmacokinetic dosages of venetoclax

Interventions

Pharmacokinetic dosages of venetoclaxOTHER

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

Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU de Grenoble

Grenoble, 38000, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

CHU de Saint-Étienne

Saint-Etienne, 42100, France

RECRUITING

Hôpitaux Nord-Ouest - Villefranche-sur-Saône

Villefranche-sur-Saône, 69400, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Michaël Philippe

CONTACT

+33478782666michael.philippe@lyon.unicancer.fr

Amine Belhabri, MD

CONTACT

amine.belhabri@lyon.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Clinical-biological cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2025

First Posted

November 24, 2025

Study Start

January 21, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

FR(4)