Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma
赞助:
Fujian Medical University
合作者:
信息的提供 (责任方):
Ting YANG，Fujian Medical University
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | January 2014 | ||
| 预计主要完成日期 | January 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Relapse rate[ Time Frame: 2 years ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma | ||
| 正式标题 ICMJE | Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in High-risk Aggressive Lymphoma | ||
| 简要概况 | 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. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2/Phase 3 | ||
| 研究设计 ICMJE | 分配: Non-Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
60 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | January 2023 | ||
| 预计主要完成日期 | January 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 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 Exclusion Criteria: - 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 | ||
| 性别 |
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| 年龄 | 最小年龄：14 Years ，最大年龄：70 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Ting YANG，Fujian Medical University | ||
| 研究赞助商 ICMJE | Fujian Medical University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Fujian Medical University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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