A Multicenter, Prospective, Single-Arm Study of Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Composite Complete Remission Rate (CR + CRi)
研究概览
简要总结
To evaluate the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML).
详细描述
This is a multicenter, prospective, single-arm clinical study evaluating the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML). Participants will receive VCC combination therapy according to the study protocol. The primary objective is to evaluate the antileukemic efficacy of the VCC regimen, while safety and tolerability will also be assessed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed acute myeloid leukemia (AML) with relapsed or refractory disease, including:
- •Refractory AML, defined as failure to achieve remission after at least one prior treatment;
- •Relapsed AML, defined as ≥5% blasts in the bone marrow after a previous remission;
- •AML arising from myelodysplastic syndrome (including CMML) or myeloproliferative neoplasms (secondary AML or therapy-related AML [t-AML]) is also eligible.
- •Age ≥18 years, regardless of sex, with an expected survival of >3 months.
- •Estimated creatinine clearance ≥50 mL/min.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × the upper limit of normal (ULN), unless the abnormality is considered attributable to leukemic organ involvement; total bilirubin ≤3.0 × ULN, unless the abnormality is considered attributable to leukemic organ involvement.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Participants must not be pregnant and must agree to use effective contraception during study treatment.
- •Ability to understand the study and willingness to provide written informed consent.
排除标准
- •Acute promyelocytic leukemia (APL).
- •Active central nervous system leukemia.
- •Clinically significant cardiovascular disease, including any of the following:
- •Clinically significant QTc prolongation (QTc >450 ms in males or >470 ms in females);
- •Ventricular tachycardia;
- •Second-degree atrioventricular block;
- •Myocardial infarction within 1 year prior to enrollment;
- •Congestive heart failure;
- •Coronary artery disease requiring medical treatment.
- •Active, uncontrolled severe infection.
- •Other non-hematologic malignancies within the previous 2 years.
- •Psychiatric disorders that may interfere with participation in the study.
- •Previous solid organ transplantation. Prior stem cell transplantation (SCT) is permitted; however, patients with graft-versus-host disease (GVHD) or those receiving ongoing immunosuppressive or GVHD-directed therapy are not eligible.
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
结局指标
主要结局
Composite Complete Remission Rate (CR + CRi)
时间窗: Up to 12 months
The proportion of participants who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following VCC treatment. Treatment response will be assessed according to the response criteria specified in the study protocol.
次要结局
- 1-Year Progression-Free Survival (PFS)(Up to 12 months)
- 1-Year Overall Survival (OS)(Up to 12 months)
- Change in Health-Related Quality of Life Assessed by EQ-5D-5L(Up to 24 months)
- Incidence of Adverse Events(Up to 12 months)
研究者
Bing, Xu
Dr. Bing Xu
The First Affiliated Hospital of Xiamen University