JPRN-jRCT2080221331已完成3 期
An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy(B1931008/3129K5-3303-WW)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 377
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •*Relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
- •*Up to 3 prior regimens containing cytotoxic chemotherapies
- •*Not candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant
排除标准
- •*Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months
- •*Anti-CD22 treatment or radioimmunotherapy within prior 6 months
- •*Contraindication to both investigator choice regimens
- •*Chronic liver disease, history of veno-occlusive disease
研究者
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3 期
An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator*s Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy.Subject with a diagnosis of CD20 and CD22- positive agressive non-Hodgin lymphomacancer of the lymphoid tissuemalign lymphnodes10025322NL-OMON39239Pfizer5
Unknown
3 期
A clinical trial to evaluate if a new combination of anticancer drugs (called inotuzumab ozogamicin and rituximab) can increase the life-span of patients with a particular type of cancer (relapsed/refractory aggressive Non-Hodgkin lymphoma)compared to other anticancer drug combinationsCTRI/2011/10/002084Pfizer Limited377
进行中（未招募）
不适用
An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator’s Choice Therapy in Subjects With Relapsed or Refractory, CD22- Positive, Follicular B-Cell Non Hodgkin’s LymphomaRelapsed or refractory, CD22-Positive, follicular B-cell Non Hodgkin's LymphomaMedDRA version: 9.1Level: LLTClassification code 10029473Term: Nodular (follicular) lymphomaEUCTR2007-000219-27-PTWyeth Research Division of Wyeth Pharmaceuticals Inc978
已完成
不适用
An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator’s Choice Therapy in Subjects With Relapsed or Refractory, CD22- Positive, Follicular B-Cell Non Hodgkin’s Lymphoma-C82 Follicular lymphomaC82Follicular lymphomaPER-040-08ABORATORIOS WYETH S.A.,
进行中（未招募）
1 期
An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator’s Choice Therapy in Subjects With Relapsed or Refractory, CD22- Positive, Follicular B-Cell Non Hodgkin’s LymphomaRelapsed or refractory, CD22-Positive, follicular B-cell Non Hodgkin's LymphomaMedDRA version: 9.1Level: LLTClassification code 10029473Term: Nodular (follicular) lymphomaEUCTR2007-000219-27-BEWyeth Pharmaceuticals Inc. acting through its division Wyeth Research, a Pfizer Company978