Venetoclax, Cladribine Plus Low-dose Cytarabine for Relapsed/Refractory Philadelphia Chromosome-negative (Ph-) B-cell Acute Lymphoblastic Leukemia (B-ALL): a Single-arm, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 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, venetoclax combined with cytarabine and venetoclax (CAV regimen) for relapsed/refractory (R/R) Philadelphia Chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL).
详细描述
Relapse is common in Ph- B-ALL and a proportion of patients present refractory to initial treatment. Treatments for these patients consist immunotherapy and conventional chemotherapy. The former is too expensive and the latter has a low remission rate. Treatment for R/R Ph- B-ALL still remains a challenge. The efficacy and safety of cladribine, venetoclax and cytarabine (CAV) has not been explored in ALL. Thus investigators design such a clinical trial to investigate the efficacy and safety of CAV regimen for R/R Ph- B-ALL.
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
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 15-70 years old.
- •Patients diagnosed with R/R Ph- B-ALL.
- •Patients with ALL must meet one of the following criteria, A or B: A: Refractory ALL disease was defined as follows: (1) failure to attain CR following exposure to at least 1 courses of standard induction therapy; B: Relapsed ALL 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.
- •ECOG performance status score less than
- •Expected survival time ≥ 12 weeks.
- •Patients 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 of 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.
- •Surgery on the main organs within the past six weeks.
- •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
干预措施: cladribine, cytarabine,venetoclax (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)
次要结局
- Overall Survival (OS)(2 years)
- Progression-Free Survival (PFS)(2 years)
- Adverse events(1 month)
研究者
Sheng-Li Xue, MD
Professor
The First Affiliated Hospital of Soochow University