NCT03695055Unknown2 期
Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in High-risk Aggressive Lymphoma
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relapse rate
研究概览
简要总结
Relapse after autologous hematopoietic stem cell transplantation (ASCT) is still challenging for high-risk aggressive lymphoma. This study was to investigate the efficacy and safety of maintenance therapy post-ASCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-70 years
- •High-risk aggressive lymphoma underwent auto-HSCT
- •Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Adequate hematological function
- •Offer informed consent
排除标准
- •Concomitant other cancer
- •Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction
- •Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome)
- •Liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%
- •Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea > 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days)
- •Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system
- •Pregnancy
研究组 & 干预措施
Arm 1
Experimental
Rituximab maintenance
干预措施: Maintenance therapy post-HSCT (Drug)
Arm 2
Active Comparator
DPP/DCEP-G alternation regimen
干预措施: Maintenance therapy post-HSCT (Drug)
结局指标
主要结局
Relapse rate
时间窗: 2 years
次要结局
- Overall survival(2 years)
- Treatment-related mortality(2 years)
研究者
Ting YANG
Prof.M.D.Ph.D
Fujian Medical University
研究点 (1)
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