ABC Maintenance Therapy for AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cohort 1 (MRD-Negative Patients): 61 subjects, Cohort 2 (MRD-Persistent Positive Patients): 43 subjects.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia (AML) in Remission. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Relapse-Free Survival (RFS) [Time frame: 1-year RFS rate]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog — Wuhan
Identifiers
NCT: NCT07521124 · Chi-Ven(Bcl-2)-Aza