A Randomized Controlled Clinical Trial Comparing Chidamide,Carmustine,Etoposide,Cytarabine and Melphalan With BEAM Regimen Combined With Autologus Hematopoietic Stem Cell Transplantation for the Treatment of Newly Diagnosed PTCL
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 2-y PFS
研究概览
简要总结
The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL.
The main question it aims to answer are:
•Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.
详细描述
This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was： 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment;
- •Renal function needs to be satisfied: creatinine clearance ≥80ml/min, creatinine less than 160μmol/L; Liver function requirements: ALT and AST≤2 times the upper limit of normal; Total bilirubin ≤2 times the upper limit of normal; Lung function should meet: FEV1, FVC, DLCO≥50% predictive value; Cardiac function must be satisfied: left ventricular ejection fraction ≥50%, asymptomatic arrhythmia.
- •Age between 18 and 65 years old, male and female;
- •ECOG physical strength score 0-1;
- •Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight;
- •Expected survival time ≥3 months;
- •Voluntarily sign written informed consent.
排除标准
- •Lymphoma involving the central nervous system
- •Active hepatitis B or C virus infection;
- •Active infection;
- •HIV infected persons;
- •Evidence of cirrhosis or liver fibrosis;
- •Ecg showed QTc > 500ms;
- •Persons with mental disabilities/unable to obtain informed consent;
- •Patients with drug or chronic alcohol abuse that may affect the evaluation of study results;
- •Pregnant and lactating women and women of childbearing age who do not want to take contraceptive measures;
- •The researcher determines that it is not suitable to participate in this study
研究组 & 干预措施
C-BEAM
Chidemide，carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation
干预措施: C-BEAM Regimen (Drug)
BEAM
carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation
干预措施: BEAM Regimen (Drug)
结局指标
主要结局
2-y PFS
时间窗: 2 years
2-year PFS
次要结局
- 2-year OS(2 years)
- CR rate at 3 months post-transplant evalutation(2 years)
- hematopoietic reconstitution time(2 years)
- Non-recurrent mortality(2 years)