Efficacy and Safety of Maintenance Treatment With Chidamide, Venetoclax, and Azacitidine for Treatment-Naive Acute Myeloid Leukemia Patients Achieving Complete Remission: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Relapse-Free Survival (RFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Cohort 1 (MRD-Negative Patients): 61 subjects (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.
干预措施: Cohort 2 (MRD-Persistent Positive Patients): 43 subjects (Drug)
结局指标
主要结局
Relapse-Free Survival (RFS)
时间窗: 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.
次要结局
- Overall Survival (OS)(2-year)
- Event-Free Survival (EFS)(2-year)
- Duration of Remission (CRd)(2-year)
- Safety Evaluation(2-year)
- Analysis of MRD Dynamics and Prognostic Impact(2-year)