AMLPhase 3NCT07539818
Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML
A Phase 3 study testing Venetoclax and Azacitidine in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective, multicenter, randomized, open-label, phase III trial evaluating the efficacy and safety of azacitidine plus venetoclax versus azacitidine alone as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR) or CR with incomplete count… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- AML
- What is being tested?
- Venetoclax and Azacitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 788 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 1 Apr 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of AML per WHO 2022 or ICC criteria, or MDS/AML (10-20% blasts) per ICC
- Age ≥14 and <75 years
- ECOG performance status 0-2
- First complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation
- Received at least 2 cycles of intermediate- or high-dose cytarabine (cumulative dose ≥6 g/m² per cycle)
- Time from first CR/CRi to enrollment ≤10 months, and time from last treatment to enrollment ≤3 months
- MRD-negative or low-level MRD detectable; MRD-positive patients are excluded
- Signed informed consent
Who cannot join
- Acute promyelocytic leukemia with PML-RARA
- AML with BCR-ABL
- Active central nervous system involvement
- Prior allogeneic hematopoietic stem cell transplantation
- Planned allogeneic HSCT within 6 months
- Deemed unsuitable by investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Hui Wei, MD, 86-13132507161, weihui@ihcams.ac.cn
About this study
Official title: A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia
This is a prospective, multicenter, randomized, open-label, phase III trial evaluating the efficacy and safety of azacitidine plus venetoclax versus azacitidine alone as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation. Eligible patients aged 14 to 74 years are randomized 1:1 to receive either azacitidine 50 mg/m²/day on days 1-5 every 6 weeks for up to 12 cycles, or the same azacitidine regimen combined with venetoclax 400 mg on days 1-7 per cycle. The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of relapse (CIR), minimal residual disease (MRD) conversion rate, and safety. A total of 788 patients are planned with stratification by prior venetoclax exposure and MRD status.
- Conditions
- AML
- Being tested
- Venetoclax, Azacitidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
400 mg on days 1-7, every 6 weeks for 12 cycles
AzacitidineDrug
50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| VA | Experimental | Azacitidine 50 mg/m²/day on days 1-5 + Venetoclax 400 mg on days 1-7, every 6 weeks for 12 cycles Receives: Drug: Venetoclax; Drug: Azacitidine |
| AZA | Active comparator | Azacitidine 50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles Receives: Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival
Measured: up to 2 years
Secondary outcomes (8)
Overall Survival (OS)
Measured: up to 2 years
Relapse-Free Survival (RFS)
Measured: up to 2 years
Complete Remission Duration (CRd)
Measured: up to 1 year
DFS-MRD
Measured: Up to 2 years
RFS-MRD
Measured: Up to 2 years
Cumulative Incidence of Relapse (CIR)
Measured: Up to 5 years
CIR-MRD
Measured: up to 5 years
MRD Negativity Conversion Rate
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 May 2026
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- 788 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539818
- Sponsor's protocol ID
- IIT2026028
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07539818
- Acronym / sponsor ID
- IIT2026028
- Conditions
- AML
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 788 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 20 Apr 2026 (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, randomized, open-label, phase III trial evaluating the efficacy and safety of azacitidine plus venetoclax versus azacitidine alone as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation. Eligible patients aged 14 to 74 years are randomized 1:1 to receive either azacitidine 50 mg/m²/day on days 1-5 every 6 weeks for up to 12 cycles, or the same azacitidine regimen combined with venetoclax 400 mg on days 1-7 per cycle. The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of relapse (CIR), minimal residual disease (MRD) conversion rate, and safety. A total of 788 patients are planned with stratification by prior venetoclax exposure and MRD status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA | Experimental | Drug: Venetoclax, Drug: AzacitidineAzacitidine 50 mg/m²/day on days 1-5 + Venetoclax 400 mg on days 1-7, every 6 weeks for 12 cycles |
| AZA | Active comparator | Drug: AzacitidineAzacitidine 50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of AML per WHO 2022 or ICC criteria, or MDS/AML (10-20% blasts) per ICC
- Age ≥14 and <75 years
- ECOG performance status 0-2
- First complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation
- Received at least 2 cycles of intermediate- or high-dose cytarabine (cumulative dose ≥6 g/m² per cycle)
Key exclusion criteria (6 listed)
- Acute promyelocytic leukemia with PML-RARA
- AML with BCR-ABL
- Active central nervous system involvement
- Prior allogeneic hematopoietic stem cell transplantation
- Planned allogeneic HSCT within 6 months
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 |
|---|---|---|
| Venetoclax400 mg on days 1-7, every 6 weeks for 12 cycles | Drug | VA |
| Azacitidine50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles | Drug | AZA, VA |
Primary outcome
Disease-Free Survival
Time frame: up to 2 years
8 secondary outcomes
Overall Survival (OS)
Time frame: up to 2 years
Relapse-Free Survival (RFS)
Time frame: up to 2 years
Complete Remission Duration (CRd)
Time frame: up to 1 year
DFS-MRD
Time frame: Up to 2 years
RFS-MRD
Time frame: Up to 2 years
Cumulative Incidence of Relapse (CIR)
Time frame: Up to 5 years
CIR-MRD
Time frame: up to 5 years
MRD Negativity Conversion Rate
Time frame: up to 5 years
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 26 Oct 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.
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 AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 8 inclusion and 6 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 26 Oct 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 China. 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 Hui Wei, MD (13132507161, weihui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (time frame: up to 2 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 26 Oct 2026.