CTRI/2011/10/002084Other3 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
试验速览
- 阶段
- 3 期
- 状态
- Other
- 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
入选标准
- •a. Ages Eligible for Study: 18 Years and older
- •b. Genders Eligible for Study: Both
- •c. Accepts Healthy Volunteers: No
- •1.relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
- •2.up to 3 prior regimens containing cytotoxic chemotherapies
- •3.not candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant
- •Note: There is no upper limit for inclusion criteria for this trial.
排除标准
- •1.Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months
- •2.anti-CD22 treatment or radioimmunotherapy within prior 6 months
- •3.contraindication to both investigator choice regimens
- •4.chronic liver disease, history of veno-occlusive disease
研究者
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