Acute Myeloid LeukemiaPhase 2STOP VENNCT06557421
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
A Phase 2 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are: Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA… 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?
- Venetoclax and Azacitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2026to 1 Nov 2028
- Phase
- Phase 2
- 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
- Female/Male ≥ 18 years of age;
- Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;
- VEN-AZA given as first-line treatment;
- Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses;
- Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh);
- Absence of detectable minimal residual disease (MRD) performed locally (i.e. MRDneg defined as MCF MRD <0.1% of CD45 expressing cells with the target immunophenotype in bone marrow, or NPM1 or RUNX1-RUNX1T1 or CBFB-MYH11 MRD copy numbers <0.1% in the blood);
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- ECOG <3;
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- Affiliated to the French Social Security or beneficiary of such a health Insurance;
- Signed informed consent.
- Non inclusion Criteria:
- VEN-AZA given as salvage therapy;
- Prior allogeneic stem cell transplant;
- Discontinuation of treatment because of absence or loss of response;
- Patient in emergency situation or unable to give consent;
- Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli-Calmettes
Marseille, 13273
Jihane PAKRADOUNI, PharmD, PhD, 33491223778, drci.up@ipc.unicancer.fr
Laurie-Anne GOUTY, PhD, 33491223778, drci.up@ipc.unicancer.fr
About this study
The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:
- Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival.
- Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.
Read more
Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.
Participants will:
- Stop VEN-DASA treatment
- Be closely monitored by regular evaluation of the disease
- Conditions
- Acute Myeloid Leukemia
- Being tested
- 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.
VenetoclaxDrug
complete discontinuation of Venetoclax
AzacitidineDrug
complete discontinuation of Azacitidine
| Study group | Role | What they receive |
|---|---|---|
| VEN-AZA de-escalation | Experimental | VEN-AZA de-escalation Receives: Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first.
Measured: 24 months
Secondary outcomes (13)
Absolute duration of hematologic response, defined as the time from inclusion to relapse or death.
Measured: 24 months
Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death.
Measured: 24 months
Cumulative incidence of relapse, defined as the probability of relapse over time.
Measured: 24 months
Overall survival, defined as the time from inclusion (VEN-AZA de-escalation) to death.
Measured: 24 months
Second complete remission occurence.
Measured: 24 months
Time to second remission, defined as the time between date of treatment re initiation and complete remission.
Measured: 24 months
Hospitalization rate associated with VEN-AZA de-escalation.
Measured: 24 months
Transfusion occurrence associated with VEN-AZA de-escalation.
Measured: 24 months
Grade 3-4 adverse events occurence associated with VEN-AZA de-escalation.
Measured: 24 months
Correlation between age and duration of response and survival after VEN-AZA de-escalation.
Measured: 24 months
Correlation between FAB classification and duration of response and survival after VEN-AZA de-escalation.
Measured: 24 months
Correlation between cytogenetic and molecular alterations and duration of response and survival after VEN-AZA de-escalation.
Measured: 24 months
Correlation between number of prior VEN-AZA cycles and duration of response and survival after VEN-AZA de-escalation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start4 Feb 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (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 Institut Paoli-CalmettesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain GARCIAZ, MD PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557421
- Sponsor's protocol ID
- STOP VEN-IPC 2024-001
- Acronym
- STOP VEN
- Status last verified
- Mar 2026
- First submitted
- 9 Aug 2024
- Last updated
- 13 Mar 2026
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
- ClinicalTrials.gov ID
- NCT06557421
- Acronym / sponsor ID
- STOP VEN / STOP VEN-IPC 2024-001
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 16 Aug 2024 (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 goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:
- Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival.
- Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.
Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.
Participants will:
- Stop VEN-DASA treatment
- Be closely monitored by regular evaluation of the disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VEN-AZA de-escalation | Experimental | Drug: Venetoclax, Drug: AzacitidineVEN-AZA de-escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female/Male ≥ 18 years of age;
- Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;
- VEN-AZA given as first-line treatment;
- Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses;
- Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh);
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Venetoclaxcomplete discontinuation of Venetoclax | Drug | VEN-AZA de-escalation |
| Azacitidinecomplete discontinuation of Azacitidine | Drug | VEN-AZA de-escalation |
Primary outcome
Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first.
Time frame: 24 months
13 secondary outcomes
Absolute duration of hematologic response, defined as the time from inclusion to relapse or death.
Time frame: 24 months
Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death.
Time frame: 24 months
Cumulative incidence of relapse, defined as the probability of relapse over time.
Time frame: 24 months
Overall survival, defined as the time from inclusion (VEN-AZA de-escalation) to death.
Time frame: 24 months
Second complete remission occurence.
Time frame: 24 months
Time to second remission, defined as the time between date of treatment re initiation and complete remission.
Time frame: 24 months
Hospitalization rate associated with VEN-AZA de-escalation.
Time frame: 24 months
Transfusion occurrence associated with VEN-AZA de-escalation.
Time frame: 24 months
Grade 3-4 adverse events occurence associated with VEN-AZA de-escalation.
Time frame: 24 months
Correlation between age and duration of response and survival after VEN-AZA de-escalation.
Time frame: 24 months
Correlation between FAB classification and duration of response and survival after VEN-AZA de-escalation.
Time frame: 24 months
Correlation between cytogenetic and molecular alterations and duration of response and survival after VEN-AZA de-escalation.
Time frame: 24 months
Correlation between number of prior VEN-AZA cycles and duration of response and survival after VEN-AZA de-escalation.
Time frame: 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 13 Mar 2026.
- 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.
Sylvain GARCIAZ, MD PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by Institut Paoli-Calmettes at 1 site 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 16 inclusion and 0 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jihane PAKRADOUNI, PharmD,PhD (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first. (time frame: 24 months). 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 13 Mar 2026.