NCT07521124Not yet recruiting
ABC Maintenance Therapy for AML
Efficacy and Safety of Maintenance Treatment With Chidamide, Venetoclax, and Azacitidine for Treatment-Naive Acute Myeloid Leukemia Patients Achieving Complete Remission: A Multicenter Study
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 2 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07521124
What you commit to
- Study type: Interventional
- Planned participants: 104
- From 1 Jun 2026 to the primary completion date, 1 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
Lab values
- 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.
Other
- Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML.
- Pregnant women.
- Patients with Relapsed or Refractory (R/R) AML.
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union Hospital, Tongji Medical College Huazhong University of Science and Technolog Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.