NCT03629873Unknown2 期
A Phase 2 Study Evaluating Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2018年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Progression-free survival rate
研究概览
简要总结
This is a single arm, multi-center, open study to evaluating efficacy and safety of Chi-BEAC combining with auto-HSCT to treat aggressive lymphoma Subjects
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry, aaIPI≥2 or double-hit lymphoma, as first-line consolidation; diffuse large B cell lymphoma as second-line consolidation therapy; peripheral T-cell lymphoma except ALK-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy.
- •Adequate organ system function including:
- •Creatinine clearance rate ≥ 80ml/min and creatinine < 160μmol/L ALT/AST ≤ 2 upper limit of normal Total Bilirubin < 2 upper limit of normal FEV1、FVC and DLCO ≥ 50% predictive value Left ventricular ejection fraction ≥ 50% No Symptomatic arrhythmia
- •Age 18-60 years, male and female
- •ECOG score 0-1
- •Number of neutrophil ≥ 1.5×10^9/L, number of platelet ≥ 70×10^9/L, concentration of hemoglobin ≥ 90g/L, number of CD34+ cells ≥ 2.0×10^6/kg
- •Expected survival ≥ 12 weeks
- •Volunteered to participate in this study and signed informed consent
排除标准
- •Have evidence of CNS lymphoma
- •Relapse after autologous hematopoietic stem cell transplantation
- •Active hepatitis B or hepatitis C virus infection
- •Severe active infection
- •HIV-infected persons
- •Liver cirrhosis or hepatic fibrosis
- •QTc > 500ms
- •Have mental disorder or unable to sign informed consent
- •History of drug abuse and intemperance
- •Women who are pregnant or lactating or have breeding intent
- •The investigators believe that any increase in the risk of the subject or interference with the results of the trial
结局指标
主要结局
Progression-free survival rate
时间窗: 2 years after transplantation
次要结局
- Overall survival(2 years after transplantation)
- Complete remission(3 months after transplantation)
- Time of hematopoietic reconstitution(15 days, 1 month)
- Non-relapse mortality(2 years)
研究者
WEI XU
Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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