Acute Myeloid Leukemia (AML) in RemissionABC-MaintNCT07521124
ABC Maintenance Therapy for AML
A study testing Cohort 1 (MRD-Negative Patients): 61 subjects and Cohort 2 (MRD-Persistent Positive Patients): 43 subjects in people with Acute Myeloid Leukemia (AML) in Remission, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Study Objectives: To evaluate the Relapse-Free Survival (RFS) and 1-year RFS rate in patients with Acute Myeloid Leukemia (AML) receiving maintenance therapy with Chidamide combined with Venetoclax and Azacitidine. Study Design: Prospective, Multicenter, Interventional Cohort Study. Total Enrollment: 104 subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML) in Remission
- What is being tested?
- Cohort 1 (MRD-Negative Patients): 61 subjects and Cohort 2 (MRD-Persistent Positive Patients): 43 subjects
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years with newly diagnosed Acute Myeloid Leukemia (AML)
- Patients who have achieved their first Complete Remission (CR) or Complete Remission with incomplete hematologic recovery (CRi) at the time of enrollment, following induction therapy with intensive chemotherapy and at least 2 cycles of consolidation therapy. Remission must have been achieved within 4 months (±7 days) prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
- Women of childbearing potential are eligible if they meet the following conditions:
- A negative serum or urine pregnancy test is performed within 10-14 days prior to enrollment, and a second negative pregnancy test is performed within 24 hours prior to the initiation of treatment. Both negative results are required to meet the criteria for treatment initiation.
- They agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug.
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- Male patients with female partners of childbearing potential are eligible if they agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug.
- Women of childbearing potential must comply with scheduled pregnancy tests.
- Ability to understand and sign the Informed Consent Form (ICF).
Who cannot join
- Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML.
- Patients with a history of extramedullary leukemia, unless central nervous system (CNS) involvement is controlled.
- Laboratory values that do not meet the following criteria: Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); Serum Creatinine ≤ 2.5 × ULN; Absolute Neutrophil Count (ANC) > 0.5 × 10⁹/L; Platelet Count ≥ 30 × 10⁹/L.
- Uncontrolled comorbidities, including but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, or psychiatric illness/social situations that would compromise compliance with the protocol.
- History of AML that was refractory to or did not achieve remission with prior treatment containing Venetoclax, Chidamide, or Azacitidine.
- History of hypersensitivity to any component of the study protocol.
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- Pregnant women.
- Patients with active Central Nervous System (CNS) disease.
- Patients with Relapsed or Refractory (R/R) AML.
- Patients who have undergone Hematopoietic Stem Cell Transplantation (HSCT).
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog
Wuhan
Weiming Li, Ph.D., 027-85726375, lee937@126.com
About this study
Official title: Efficacy and Safety of Maintenance Treatment With Chidamide, Venetoclax, and Azacitidine for Treatment-Naive Acute Myeloid Leukemia Patients Achieving Complete Remission: A Multicenter Study
Study Objectives:
To evaluate the Relapse-Free Survival (RFS) and 1-year RFS rate in patients with Acute Myeloid Leukemia (AML) receiving maintenance therapy with Chidamide combined with Venetoclax and Azacitidine.
Read more
Study Design:
Prospective, Multicenter, Interventional Cohort Study.
Total Enrollment:
104 subjects. Cohort 1 (MRD-Negative Patients): 61 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Cohort 2 (MRD-Persistent Positive Patients): 43 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
- Being tested
- Cohort 1 (MRD-Negative Patients): 61 subjects, Cohort 2 (MRD-Persistent Positive Patients): 43 subjects
- Keywords
- Acute Myeloid Leukemia (AML), Chidamide, ABC
- 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.
Cohort 1 (MRD-Negative Patients): 61 subjectsDrug
Also called MRD-Negative Patients
Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
Cohort 2 (MRD-Persistent Positive Patients): 43 subjectsDrug
Also called MRD-Persistent Positive Patients
Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (MRD-Negative Patients): 61 subjects | Experimental | Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Receives: Drug: Cohort 1 (MRD-Negative Patients): 61 subjects |
| Cohort 2 (MRD-Persistent Positive Patients): 43 subjects | Experimental | Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Receives: Drug: Cohort 2 (MRD-Persistent Positive Patients): 43 subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival (RFS)
Relapse-Free Survival (RFS) is defined as the time interval from the date of enrollment (or achievement of Complete Remission) to the date of hematologic relapse, the occurrence of a second primary malignancy, or death from any cause, whichever occurs first.
● Endpoint Event: An "event" for RFS analysis is recorded when:
- Hematologic Relapse: The patient shows definitive evidence of AML recurrence (e.g., blast count > 5% in bone marrow, or reappearance of blasts in peripheral blood).
- Death: The patient dies due to any cause while in remission.
Measured: 1-year RFS rate
Secondary outcomes (5)
Overall Survival (OS)
Overall Survival (OS) is defined as the time interval from the date of enrollment (or randomization) to the date of death from any cause.
Endpoint Event: The primary event for the analysis is death from any cause (whether related to the disease, treatment, or other causes).
Censoring: Patients who are still alive at the time of the final data cutoff, or who are lost to follow-up, will be censored at the date of their last known contact (last known alive date).
Measured: 2-year
Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time interval from the date of enrollment (or start of treatment) to the date of the first occurrence of any of the following events:
Relapse: Hematologic recurrence of Acute Myeloid Leukemia (e.g., reappearance of blasts in bone marrow or peripheral blood).
Death: Death from any cause (whether related to the disease, treatment, or other causes).
Treatment Failure: (Optional, depending on protocol strictness) Failure to achieve response, or discontinuation of treatment due to toxicity or progressive disease before relapse.
Censoring:
Patients who do not experience any of the above events by the time of the final data cutoff, or who are lost to follow-up, will be censored at the date of their last adequate assessment.
Measured: 2-year
Duration of Remission (CRd)
Duration of Remission (CRd) is defined as the time interval from the date of first documented Complete Remission (CR) (or the date of enrollment if the patient is already in CR at baseline) to the date of relapse or death from any cause, whichever occurs first.
Endpoint Event: An "event" for CRd analysis is recorded when:
Relapse: The patient shows definitive evidence of AML recurrence (e.g., blast count > 5% in bone marrow, or reappearance of blasts in peripheral blood).
Death: The patient dies while in remission. Censoring: Patients who are still alive and have not relapsed at the time of the final data cutoff are censored at the date of their last adequate assessment.
Measured: 2-year
Safety Evaluation
All Adverse Events (AEs) occurring during the clinical study, including abnormal clinical symptoms, vital signs, and laboratory findings, will be described in detail.
Clinical characteristics, severity, onset time, duration, management, and outcomes of these events will be recorded.
The relationship between these events and the study drugs will be assessed. Hematologic and non-hematologic toxicities will be graded according to the NCI-CTCAE v5.0 criteria.
Measured: 2-year
Analysis of MRD Dynamics and Prognostic Impact
Evaluation of the kinetic impact of Chidamide combined with Venetoclax and Azacitidine maintenance therapy on Measurable Residual Disease (MRD) and its correlation with prognosis.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 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 Leukemia (AML) in RemissionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Total Enrollment: 104 subjects. Cohort 1 (MRD-Negative Patients): 61 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Cohort 2 (MRD-Persistent Positive Patients): 43 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521124
- Sponsor's protocol ID
- Chi-Ven(Bcl-2)-Aza
- Acronym
- ABC-Maint
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Maintenance Treatment With Chidamide, Venetoclax, and Azacitidine for Treatment-Naive Acute Myeloid Leukemia Patients Achieving Complete Remission: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07521124
- Acronym / sponsor ID
- ABC-Maint / Chi-Ven(Bcl-2)-Aza
- Keywords
- Acute Myeloid Leukemia (AML), Chidamide, ABC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 9 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.
Study Objectives:
To evaluate the Relapse-Free Survival (RFS) and 1-year RFS rate in patients with Acute Myeloid Leukemia (AML) receiving maintenance therapy with Chidamide combined with Venetoclax and Azacitidine.
Study Design:
Prospective, Multicenter, Interventional Cohort Study.
Total Enrollment:
104 subjects. Cohort 1 (MRD-Negative Patients): 61 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Cohort 2 (MRD-Persistent Positive Patients): 43 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Total Enrollment: 104 subjects. Cohort 1 (MRD-Negative Patients): 61 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Cohort 2 (MRD-Persistent Positive Patients): 43 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (MRD-Negative Patients): 61 subjects | Experimental | Drug: Cohort 1 (MRD-Negative Patients): 61 subjectsChidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. |
| Cohort 2 (MRD-Persistent Positive Patients): 43 subjects | Experimental | Drug: Cohort 2 (MRD-Persistent Positive Patients): 43 subjectsChidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 to 80 years with newly diagnosed Acute Myeloid Leukemia (AML)
- Patients who have achieved their first Complete Remission (CR) or Complete Remission with incomplete hematologic recovery (CRi) at the time of enrollment, following induction therapy with intensive chemotherapy and at least 2 cycles of consolidation therapy. Remission must have been achieved within 4 months (±7 days) prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
- Women of childbearing potential are eligible if they meet the following conditions:
- Male patients with female partners of childbearing potential are eligible if they agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug.
Key exclusion criteria (10 listed)
- Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML.
- Patients with a history of extramedullary leukemia, unless central nervous system (CNS) involvement is controlled.
- Laboratory values that do not meet the following criteria: Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); Serum Creatinine ≤ 2.5 × ULN; Absolute Neutrophil Count (ANC) > 0.5 × 10⁹/L; Platelet Count ≥ 30 × 10⁹/L.
- Uncontrolled comorbidities, including but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, or psychiatric illness/social situations that would compromise compliance with the protocol.
- History of AML that was refractory to or did not achieve remission with prior treatment containing Venetoclax, Chidamide, or Azacitidine.
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 |
|---|---|---|
| Cohort 1 (MRD-Negative Patients): 61 subjectsAlso: MRD-Negative PatientsChidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. | Drug | Cohort 1 (MRD-Negative Patients): 61 subjects |
| Cohort 2 (MRD-Persistent Positive Patients): 43 subjectsAlso: MRD-Persistent Positive PatientsChidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. | Drug | Cohort 2 (MRD-Persistent Positive Patients): 43 subjects |
Primary outcome
Relapse-Free Survival (RFS)
Time frame: 1-year RFS rate
Relapse-Free Survival (RFS) is defined as the time interval from the date of enrollment (or achievement of Complete Remission) to the date of hematologic relapse, the occurrence of a second primary malignancy, or death from any cause, whichever occurs first. ● Endpoint Event: An "event" for RFS analysis is recorded when: 1. Hematologic Relapse: The patient shows definitive evidence of AML recurrence (e.g., blast count > 5% in bone marrow, or reappearance of blasts in peripheral blood). 2. Death: The patient dies due to any cause while in remission.
5 secondary outcomes
Overall Survival (OS)
Time frame: 2-year
Event-Free Survival (EFS)
Time frame: 2-year
Duration of Remission (CRd)
Time frame: 2-year
Safety Evaluation
Time frame: 2-year
Analysis of MRD Dynamics and Prognostic Impact
Time frame: 2-year
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 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 study testing Cohort 1 (MRD-Negative Patients): 61 subjects and Cohort 2 (MRD-Persistent Positive Patients): 43 subjects in people with Acute Myeloid Leukemia (AML) in Remission, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 9 inclusion and 10 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 9 Apr 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.
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 Weiming Li, Ph.D. (027-85726375, lee937@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (RFS) (time frame: 1-year RFS rate). 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 9 Apr 2026.