NCT05657639招募中2 期
Venetoclax, Cladribine Plus Low-dose Cytarabine for Relapsed/Refractory Acute Myeloid Leukemia: a Multicenter, Randomized, Controlled Study
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This study aims to investigate the efficacy and safety of cladribine, combined with low-dose cytarabine and venetoclax (CAV regimen) for relapsed/refractory acute myeloid leukemia (R/R AML).
详细描述
Patients with relapse/refractory (R/R) acute myeloid leukemia often show resistance to conventional chemotherapy and have dismal prognosis. Salvage therapy using venetoclax combined with hypomethylation drugs achieved an overall response rate of only approximately 40% in R/R AML. Cladribine, a purine analogue, exerts cytotoxic, proapoptotic, and antiproliferative effects on AML cells.The efficacy of cladribine plus cytarabine and venetoclax in R/R AML has not been reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16-70 years old.
- •Diagnosed with R/R AML.
- •Patients with AML must meet one of the following criteria, A or B: A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) < 50% and > 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows:
- •(1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.
- •4. ECOG performance status score less than
- •Expected survival time ≥12 weeks.
- •Without serious heart, lung, liver, or kidney dysfunction.
- •Able to understand and provide informed consent.
排除标准
- •Patients who are allergic to the study drug or drugs with similar chemical structures.
- •Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
- •Active infection.
- •Active bleeding.
- •Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
- •Patients with mental disorders or other conditions.
- •Liver function abnormalities (total bilirubin > 1.5 times of the upper limit of the normal range, ALT/AST > 2.5 times of the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal dysfunction (Ccr<50ml/h).
- •Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
- •Patients who relapsed after allogeneic hematopoietic stem cell transplantation.
- •Drug abuse or long-term alcohol abuse that would affect the evaluation results.
- •Patients who have received organ transplants.
- •Patients not suitable for the study according to the investigator's assessment.
研究组 & 干预措施
CAV regimen
Experimental
干预措施: CAV Regimen (Drug)
MEC regimen
Active Comparator
干预措施: MEC Regimen (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: ORR assessment is measured on days 21 from the start of CAV regimen
The overall response (completed remission, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission)
次要结局
- Event-free survival (EFS)(2 years)
- Treatment-related mortality (TRM)(2 months)
- Adverse events (AEs)(2 months)
- Overall Survival (OS)(2 years)
研究者
Sheng-Li Xue, MD
Professor
The First Affiliated Hospital of Soochow University
研究点 (1)
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