Leukemia, B-Cell, ChronicPhase 3SEVENAZANCT07082452
A Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction
A Phase 3 study testing Venetoclax and Azacitidine in people with Leukemia, B-Cell, Chronic and Leukemia, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Combination of azacitidine (AZA) for 7 days every 28 days with a continuous daily exposure to Venetoclax (VEN), an oral bcl-2 inhibitor, is now approved for the treatment of acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy due to age (>75 years) or comorbidities. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Leukemia, B-Cell, Chronic, Leukemia
- What is being tested?
- Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Mar 2031
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject must have confirmation of AML by WHO 2022 criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or co-morbidities.
- Subject must be ≥ 60 years of age.
- Subject must have a projected life expectancy of at least 12 weeks.
- Subject must be considered ineligible for induction therapy defined by the following:
- 75 years of age OR
- 60 to 74 years of age with at least one of the following co-morbidities:
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- ECOG Performance Status of 2 or 3;
- Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina;
- DLCO ≤ 65% or FEV1 ≤ 65%;
- Severe Renal impairment: Creatinine clearance ≥ 30 mL/min to < 45 ml/min
- Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × ULN
- Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the coordinator before study enrollment
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status (Appendix 4):
- 0 to 2 for subject ≥ 75 years of age.
- 0 to 3 for subject ≥ 60 to 74 years of age.
- Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula.
- Subject must have adequate liver function as demonstrated by:
- Aspartate aminotransferase (AST) ≤ 3.0 × ULN*
- Alanine aminotransferase (ALT) ≤ 3.0 × ULN*
- Bilirubin ≤ 1.5 × ULN*.
- ( Unless considered to be due to leukemic organ involvement. Subjects who are < 75 years of age may have a bilirubin of ≤ 3.0 × ULN)
- Female subjects must be either postmenopausal (amenorrhea for at least 12 months with no alternative medical reasons) or surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Non-sterile male subjects must use contraceptive methods with partner(s) prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. Male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug.
- Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
- Patients must be affiliated to a social security system or beneficiary of the same
- Patients shall be eligible to undergo Azacitidine and Venetoclax treatment and BM aspiration. Patients who either do not consent to a BM aspiration will not be eligible.
Who cannot join
- Subject has received treatment with the following:
- Hypomethylating agent, venetoclax and/or any chemo-therapeutic agent for Myelodysplastic syndrome (MDS).
- Chimeric Antigen Receptor (CAR)-T cell therapy.
- Experimental therapies for MDS or Acute Myeloid Leukemia (AML).
- Current participation in another research or observational study.
- Subject has history of myeloproliferative neoplasm [MPN], including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
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- Subject has favorable risk cytogenetics such as t(8;21), inv(16), t(16;16) or t(15;17) as per the NCCN Guidelines Version 2, 2016 for Acute Myeloid Leukemia.
- Subject has acute promyelocytic leukemia
- Subject has known active CNS involvement with AML.
- Known human immunodeficiency virus HIV
- Known hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months.
- Subject has a cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
- Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study.
- Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.
- Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
- Subject has a history of other malignancies prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and considered in remission for 3 years.
- Subject has a white blood cell count > 25 × 109/L. (Hydroxyurea is permitted to meet this criterion.)
- Subject has hypersensitivity to the active substances of any of the excipients
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- NB: patients with IDH1-mutant AML will not be formally excluded from the study. However, investigators are strongly encouraged to prefer treatment combining Azacitidine and Ivosidenib (AGILE phase III trial).
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
Gustave Roussy
Villejuif, 94805
Jean-Luc JOANNIC, PhD, +33 (0)1 42 11 47 94, jeanluc.joannic@gustaveroussy.fr
About this study
Official title: A Randomized, Open-labelled, Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction
Combination of azacitidine (AZA) for 7 days every 28 days with a continuous daily exposure to Venetoclax (VEN), an oral bcl-2 inhibitor, is now approved for the treatment of acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy due to age (>75 years) or comorbidities. VEN+AZA showed significant overall response rate and survival benefit but combination carries a risk of considerable toxicity (such as profound/prolonged cytopenia and infections) before but also after remission. These toxicities make it difficult to apply the recommended treatment regimen, in particular the continuous daily intake of VEN. Recent reports suggest that reducing VEN duration per cycle seems safe and feasible. We propose to investigate a reduced-intensity VEN regimen (7-day dosing/28) versus the standard continuous VEN therapy (28-day dosing/28), combined with AZA, with the primary goal of maintaining efficacy while reducing associated toxicity.
- Conditions
- Leukemia, B-Cell, Chronic, Leukemia
- Being tested
- Venetoclax, Azacitidine
- Keywords
- Acute Myeloid Leukemia, Venetoclax Exposure, Venetoclax, Azacitidine
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Venetoclax 400 mg orally once Daily
AzacitidineDrug
75 mg/m2 Subcutaneous (SC) or intravenous (IV) Daily with a continuous 7-day scheme or on a 5-on/2-off [weekend]/2-on schedule (5-0-2) in 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Venetoclax (7 days) + Azacitidine | Experimental | Arm A (experimental): Patients will receive venetoclax for a total of seven days.
* Azacitidine 75 m Subcutaneous (SC) or intravenous (IV) Daily with a continuous 7-day scheme or on a 5-on/2-off [weekend]/2-on schedule (5-0-2) in 28-day cycle
* Venetoclax 400 mg orally once Daily on Days 1 - 7, in case of AZA treatment with a continuous 7-day scheme OR Venetoclax 400 milligram (mg) Daily on Days 1 - 5 and Day 8-9 in case of AZA treatment with a 5-0-2 scheme. Receives: Drug: Venetoclax; Drug: Azacitidine |
| Arm B: Venetoclax (28 days) + Azacitidine | Active comparator | Arm B (standard): Patients will receive venetoclax for a total of 28 days (before remission), according to VIALE-A protocol.
* Azacitidine 75 mg/m2 Subcutaneous (SC) or IV Daily with a continuous 7-day scheme or on a 5-on/2-off [weekend]/2-on schedule (5-0-2) in 28-day cycle.
* Venetoclax 400 mg orally once Daily on Days 1 - 28. Receives: Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with complete remission or complete remission with incomplete marrow recovery (CR/CRi)
This proportion will be calculated based on current IWG criteria for AML
Measured: at any time point during the study (at 30 days, 60 days, 3 years)
Secondary outcomes (10)
Overall survival (OS)
Measured: at 30 days, 60 days, 1, 2 and 3 years
Event-Free Survival (EFS)
Defined as the number of days from the date of randomization to the date of treatment failure, hematologic relapse from CR/CRh/CRi or death from any cause, whichever occurs first.
Measured: at 30 days, 60 days, 1, 2 and 3 years
Early mortality rate
Measured: At day 60
Time to first response
Defined as the number of days from the date of randomization to the date of earliest CR or CRi
Measured: at 30 days, 60 days, 1, 2 and 3 years
Time to best response
Defined as the number of days from the date of randomization to the date of CR (or CRi if patients never reached CR).
Measured: at 30 days, 60 days, 1, 2 and 3 years
Duration of response (DoR)
Among subjects who achieved CR and CRi, duration of response (DOR) will be calculated as the date of the first response to the date of first documented disease relapse, disease progression, treatment failure, or death.
Measured: at 30 days, 60 days, 1, 2 and 3 years
Venetoclax (VEN) scheme modification (dosing schedule modification, delays >2 days or discontinuation)
Defined as the proportion of CR/CRi patients that presented treatment modification not authorized by protocol as VEN schedule modification (dose, duration), delay >2 days from the initial Day of the subsequent cycle and/or temporary/definitive VEN discontinuation.
Measured: until the last cycle of treatment (up to 3 years)
Platelet transfusion requirement
measured by the number of platelet concentrates received by patient during each cycle from cycle 1 day 1 to relapse or last day of cycle 6.
Measured: At 24 weeks
Febrile neutropenia or severe infection (grade III/IV) incidence
measured by the number of episodes of febrile neutropenia or severe infection (grade III/IV) by patient during each cycle from cycle 1 day 1 to relapse or last day of cycle 6.
Measured: At 24 weeks
Hospitalization requirement and length stay
Hospitalization requirement will be defined as number of all hospitalization longer than 24h during each cycle from Cycle 1 Day 1 to relapse or last day of Cycle 6. Hospitalization length stay will be defined by the addition of number of days of each hospitalization longer than 24h during each cycle from cycle 1 day 1 to relapse or last day of cycle 6.
Measured: At 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, B-Cell, ChronicStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082452
- Sponsor's protocol ID
- 2025-521634-29-00
- Other IDs
- 2025-521634-29-00, 2025/4132, 2025
- Acronym
- SEVENAZA
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 24 Jul 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-labelled, Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction
- ClinicalTrials.gov ID
- NCT07082452
- Acronym / sponsor ID
- SEVENAZA / 2025-521634-29-00
- Conditions
- Leukemia, B-Cell, Chronic, Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax Exposure, Venetoclax, Azacitidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 24 Jul 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.
Combination of azacitidine (AZA) for 7 days every 28 days with a continuous daily exposure to Venetoclax (VEN), an oral bcl-2 inhibitor, is now approved for the treatment of acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy due to age (>75 years) or comorbidities. VEN+AZA showed significant overall response rate and survival benefit but combination carries a risk of considerable toxicity (such as profound/prolonged cytopenia and infections) before but also after remission. These toxicities make it difficult to apply the recommended treatment regimen, in particular the continuous daily intake of VEN. Recent reports suggest that reducing VEN duration per cycle seems safe and feasible. We propose to investigate a reduced-intensity VEN regimen (7-day dosing/28) versus the standard continuous VEN therapy (28-day dosing/28), combined with AZA, with the primary goal of maintaining efficacy while reducing associated toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Venetoclax (7 days) + Azacitidine | Experimental | Drug: Venetoclax, Drug: AzacitidineArm A (experimental): Patients will receive venetoclax for a total of seven days. * Azacitidine 75 m Subcutaneous (SC) or intravenous (IV) Daily with a continuous 7-day scheme or on a 5-on/2-off [weekend]/2-on schedule (5-0-2) in 28-day cycle * Venetoclax 400 mg orally once Daily on Days 1 - 7, in case of AZA treatment with a continuous 7-day scheme OR Venetoclax 400 milligram (mg) Daily on Days 1 - 5 and Day 8-9 in case of AZA treatment with a 5-0-2 scheme. |
| Arm B: Venetoclax (28 days) + Azacitidine | Active comparator | Drug: Venetoclax, Drug: AzacitidineArm B (standard): Patients will receive venetoclax for a total of 28 days (before remission), according to VIALE-A protocol. * Azacitidine 75 mg/m2 Subcutaneous (SC) or IV Daily with a continuous 7-day scheme or on a 5-on/2-off [weekend]/2-on schedule (5-0-2) in 28-day cycle. * Venetoclax 400 mg orally once Daily on Days 1 - 28. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (26 listed)
- Subject must have confirmation of AML by WHO 2022 criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or co-morbidities.
- Subject must be ≥ 60 years of age.
- Subject must have a projected life expectancy of at least 12 weeks.
- Subject must be considered ineligible for induction therapy defined by the following:
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status (Appendix 4):
Key exclusion criteria (23 listed)
- Subject has received treatment with the following:
- Subject has history of myeloproliferative neoplasm [MPN], including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- Subject has favorable risk cytogenetics such as t(8;21), inv(16), t(16;16) or t(15;17) as per the NCCN Guidelines Version 2, 2016 for Acute Myeloid Leukemia.
- Subject has acute promyelocytic leukemia
- Subject has known active CNS involvement with AML.
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 |
|---|---|---|
| VenetoclaxVenetoclax 400 mg orally once Daily | Drug | Arm A: Venetoclax (7 days) + Azacitidine, Arm B: Venetoclax (28 days) + Azacitidine |
| Azacitidine75 mg/m2 Subcutaneous (SC) or intravenous (IV) Daily with a continuous 7-day scheme or on a 5-on/2-off [weekend]/2-on schedule (5-0-2) in 28-day cycle | Drug | Arm A: Venetoclax (7 days) + Azacitidine, Arm B: Venetoclax (28 days) + Azacitidine |
Primary outcome
Proportion of subjects with complete remission or complete remission with incomplete marrow recovery (CR/CRi)
Time frame: at any time point during the study (at 30 days, 60 days, 3 years)
This proportion will be calculated based on current IWG criteria for AML
10 secondary outcomes
Overall survival (OS)
Time frame: at 30 days, 60 days, 1, 2 and 3 years
Event-Free Survival (EFS)
Time frame: at 30 days, 60 days, 1, 2 and 3 years
Early mortality rate
Time frame: At day 60
Time to first response
Time frame: at 30 days, 60 days, 1, 2 and 3 years
Time to best response
Time frame: at 30 days, 60 days, 1, 2 and 3 years
Duration of response (DoR)
Time frame: at 30 days, 60 days, 1, 2 and 3 years
Venetoclax (VEN) scheme modification (dosing schedule modification, delays >2 days or discontinuation)
Time frame: until the last cycle of treatment (up to 3 years)
Platelet transfusion requirement
Time frame: At 24 weeks
Febrile neutropenia or severe infection (grade III/IV) incidence
Time frame: At 24 weeks
Hospitalization requirement and length stay
Time frame: At 24 weeks
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 24 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Venetoclax and Azacitidine in people with Leukemia, B-Cell, Chronic and Leukemia, run by Gustave Roussy, Cancer Campus, Grand Paris 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 26 inclusion and 23 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: opening soon, as of the sponsor's last update on 24 Jul 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Christophe WILLEKENS, MD (+33 (0)1 42 11 23 79, christophe.willekens@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with complete remission or complete remission with incomplete marrow recovery (CR/CRi) (time frame: at any time point during the study (at 30 days, 60 days, 3 years)). 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 24 Jul 2025.