Chidamide, Venetoclax and Azacitidine as Ongoing Treatment for Acute Myeloid Leukemia in Remission
Tests chidamide, venetoclax and azacitidine in adults with acute myeloid leukemia in remission.
Plain-language title generated from the registry record
Registry title: ABC Maintenance Therapy for AML
Key facts
- Where
- Wuhan, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with newly diagnosed acute myeloid leukemia (AML) who are in first complete remission after intensive chemotherapy and consolidation.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML in first complete remission (CR or CRi) after induction chemotherapy and at least 2 cycles of consolidation. Remission must have been reached within 4 months (±7 days) before joining.
- Earlier treatment
- Must have had intensive induction chemotherapy and at least 2 cycles of consolidation. Must not have had AML that failed to respond to venetoclax, chidamide or azacitidine, and must not have had a stem cell transplant.
- Biomarker or test result
- Two groups: people with no measurable residual disease (MRD-negative) and people with MRD that stays positive.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL) or FAB subtype M3 AML
- Relapsed or refractory AML
- Active central nervous system (CNS) disease, or past leukemia outside the bone marrow unless CNS involvement is controlled
- Previous stem cell transplant (HSCT)
- Pregnant women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07521124, who can take part
Where in China
- Union Hospital, Tongji Medical College Huazhong University of Science and TechnologWuhan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Trial code
- NCT07521124
- Record updated
- 9 April 2026
- Original description
Study Objectives:Read full original descriptionShow less
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.
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.
Inclusion: 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; 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).
Exclusion: History of AML that was refractory to or did not achieve remission with prior treatment containing Venetoclax, Chidamide, or Azacitidine; Patients who have undergone Hematopoietic Stem Cell Transplantation (HSCT); Patients with a history of extramedullary leukemia, unless central nervous system (CNS) involvement is controlled; 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 hypersensitivity to any component of the study protocol; Patients with active Central Nervous System (CNS) disease; 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; Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML; Pregnant women; Patients with Relapsed or Refractory (R/R) AML.