NCT05149378已完成2 期
Venetoclax Based Regimen for the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年11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
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Complete Remission Rate (CRR)
研究概览
简要总结
This study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia.
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
- •Patients aged ≥ 15 and ≤ 70 years.
- •Patients diagnosed with T-ALL/LBL according to 2017 WHO lymphoid malignant disease diagnosis standard.
- •Patients with T-ALL/LBL must meet one of the following criteria, A or B.
- •A: Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction.
- •B: Relapsed T-ALL/LBL disease was defined as follows: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR.
- •ECOG performance status score less than
- •Expected survival time >3 months.
- •Patients without serious heart, lung, liver, or kidney disease.
- •Ability to understand and voluntarily 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 whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
- •Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, ALT/AST > 2.5 times 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 anomalies (serum creatinine > 1.5 times the upper limit of the normal value).
- •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 (excepting bone marrow transplantation).
- •Patients not suitable for the study according to the investigator's assessment.
研究组 & 干预措施
Venetclax combined with azacitidine
Experimental
Relapsed or refractroy acute lymphoblastic leukemia patients reveive venetclax combined with azacitidine regimen treatment.
干预措施: Venetoclax combined with azacitidine regimen (Drug)
结局指标
主要结局
Complete Remission Rate (CRR)
时间窗: At the end of Cycle 1 (each cycle is 21 days)
The complete remission rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.
Overall Response Rate (ORR)
时间窗: At the end of Cycle 1 (each cycle is 21 days)
The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.
次要结局
- Adverse events in hematological system(1 month)
- Adverse events in other organs or systems(1 month)
- Overall survial (OS)(1 year)
- Relapse-Free Survival (RFS)(1 year)
研究者
Sheng-Li Xue, MD
Prof.
The First Affiliated Hospital of Soochow University
研究点 (1)
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