Acute Myeloid LeukemiaEUREKA-VENNCT07243483
Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia
A study testing Pharmacokinetic dosages of venetoclax in people with Acute Myeloid Leukemia, run by Centre Leon Berard at 5 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Pharmacokinetic dosages of venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Jan 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amine Belhabri, MD contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre Hospitalier Pierre Oudot
Bourgoin, France
Clément Rocher, Dr, +33469157329, crocher@ghnd.fr
Clément Rocher, Dr
- Recruiting
CHU de Grenoble
Grenoble, 38000
Martin CARRÉ, Dr, 4 76 76 50 96 ext. +33, mcarre1@chu-grenoble.fr
- Recruiting
Centre Leon Berard
Lyon, 69008
Amine BELHABRI, amine.belhabri@lyon.unicancer.fr
- Recruiting
CHU de Saint-Étienne
Saint-Etienne, 42100
Emmanuelle TAVERNIER, Dr, 4 77 82 28 57 ext. +33, Emmanuelle.Tavernier@chu-st-etienne.fr
- Recruiting
Hôpitaux Nord-Ouest - Villefranche-sur-Saône
Villefranche-sur-Saône, 69400
Sylvain LAMURE, Dr, 4 74 69 87 46 ext. +33, slamure@hno.fr
About this study
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)
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Pharmacokinetic dosages of venetoclax
- Keywords
- Pharmacokinetics, Venetoclax, Pharmacodynamics, Cytologic response, Azole antifungal
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic dosages of venetoclaxOther
Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line | Experimental | Blood samples Receives: Other: Pharmacokinetic dosages of venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
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).
Measured: 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
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
Measured: 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.
Coefficient of variation of AUC and Cmin at steady state for venetoclax
Measured: From the first day of ventoclax administration and nd through study completion, at least 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start21 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical-biological cohort
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Leucémie Espoir
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243483
- Sponsor's protocol ID
- ET24-223
- Acronym
- EUREKA-VEN
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07243483
- Acronym / sponsor ID
- EUREKA-VEN / ET24-223
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Pharmacokinetics, Venetoclax, Pharmacodynamics, Cytologic response, Azole antifungal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Fédération Leucémie Espoir
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical-biological cohort
| Arm | Type | Receives |
|---|---|---|
| Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line | Experimental | Other: Pharmacokinetic dosages of venetoclaxBlood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacokinetic dosages of venetoclaxBlood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period | Other | Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line |
Primary outcome
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
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
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
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
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amine Belhabri, MD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacokinetic dosages of venetoclax in people with Acute Myeloid Leukemia, run by Centre Leon Berard at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaël Philippe (+33478782666, michael.philippe@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.