Acute Myeloid LeukemiaVENETACIBLENCT06030089
Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven
A study testing Pharmacokinetic sampling, Vital status determination and Toxicity assessments in people with Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. 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 sampling, Vital status determination and Toxicity assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Feb 2024to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient with acute myeloid leukemia (AML) not eligible for intensive chemotherapy
- Patients aged 18 or over
- Patient treated with the combination azacitidine (AZA) + venetoclax (VEN)
- Patient having signed the study informed consent form
- Patient with social security coverage
Who cannot join
- Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4
- Presence of an active, uncontrolled infection
- Patient participating or having participated in a clinical drug trial in the month prior to inclusion.
- Vulnerable persons
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE
The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Pharmacokinetic sampling, Vital status determination, Toxicity assessments, Venetoclax and azacitidine combination
- Keywords
- acute myeloid leukemia, venetoclax, azacitidine
- 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 samplingOther
4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2
Vital status determinationOther
Survival situation 12 months after start of treament
Toxicity assessmentsOther
Toxicity events
Venetoclax and azacitidine combinationDrug
Response to treatment
| Study group | Role | What they receive |
|---|---|---|
| AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax | Experimental | Newly diagnosed AML patients Receives: Other: Pharmacokinetic sampling; Other: Vital status determination; Other: Toxicity assessments; Drug: Venetoclax and azacitidine combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Measured: Before treatment
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Measured: At Day 5 of 1st round of chemotherapies
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Measured: At Day 9 of 1st round of chemotherapies
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Measured: At 12 months after start of treatment or at relapse whichever comes first
Secondary outcomes (1)
Overall survival
Evaluate the overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start26 Feb 2024
- Primary completion30 Sep 2024
- Study completion3 Mar 2025
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 Hospitalier Universitaire de NiceThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Cluzeau, Principal investigator, CHU of Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030089
- Sponsor's protocol ID
- 23-AOIP-01
- Acronym
- VENETACIBLE
- Status last verified
- Dec 2025
- First submitted
- 18 Aug 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE
- ClinicalTrials.gov ID
- NCT06030089
- Acronym / sponsor ID
- VENETACIBLE / 23-AOIP-01
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, venetoclax, azacitidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 8 Sep 2023 (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.
The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax | Experimental | Other: Pharmacokinetic sampling, Other: Vital status determination, Other: Toxicity assessments, Drug: Venetoclax and azacitidine combinationNewly diagnosed AML patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with acute myeloid leukemia (AML) not eligible for intensive chemotherapy
- Patients aged 18 or over
- Patient treated with the combination azacitidine (AZA) + venetoclax (VEN)
- Patient having signed the study informed consent form
- Patient with social security coverage
Key exclusion criteria (4 listed)
- Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4
- Presence of an active, uncontrolled infection
- Patient participating or having participated in a clinical drug trial in the month prior to inclusion.
- Vulnerable persons
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 sampling4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2 | Other | AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax |
| Vital status determinationSurvival situation 12 months after start of treament | Other | AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax |
| Toxicity assessmentsToxicity events | Other | AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax |
| Venetoclax and azacitidine combinationResponse to treatment | Drug | AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax |
Primary outcome
Plasmatic dosage
Time frame: Before treatment
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage
Time frame: At Day 5 of 1st round of chemotherapies
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage
Time frame: At Day 9 of 1st round of chemotherapies
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage
Time frame: At 12 months after start of treatment or at relapse whichever comes first
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
1 secondary outcome
Overall survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thomas Cluzeau principal investigator
CHU of Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacokinetic sampling, Vital status determination and Toxicity assessments in people with Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Nice at 2 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 4 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic dosage (time frame: Before treatment). The study lists 4 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 16 Dec 2025.