JPRN-UMIN000008145已完成2 期
Phase 2 study evaluating the efficacy and safety of the combination of Bendamustine, Rituximab and Dexamethazone (RBenda-D) for treatment of CD20-positive relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. - Phase 2 study of Bendamustine, Rituximab and Dexamethazone(RBenda-D) for treatment of CD20-positive relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Kyoto Prefectural University of Medicine/K-LSG0 个研究点目标入组 33 人开始时间: 2012年6月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
The ORR was 88% with 58% attaining CR/CRu. A median follow-up time for all patients was 37 months. The 3-year PFS and OS rates were 75.5 +/- 8.1% (standard error) and 85.5 +/- 6.8%, respectively. The leading adverse event was myelosuppression. Incidence of grade 3-4 leukocytope nia, neutropenia, and lymphocytopenia was 55%, 67%, and 91%, respectively. The most frequent nonhematological adverse events were CMV antigenemia and rash (33% and 30%, respectively).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients are pregnant or lactating women. Patients (<1 year after menopause without surgical infertility) can not or will not use birth control during the treatment. 2. Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 3. Patients have mental disease or disorder with difficulty in participating in the clinical trial. 4. HBs antigen positive 5. HCV antibody positive 6. HIV antibody positive 7. Patients have much tumor cell in peripheral blood (>=25,000/microL). 8. Patients received allogeneic hematopoietic [hemopoietic] stem cell transplant. 9. Patients have interstitial lung disease or fibroid lung. 10. Patients have CNS invasion. 11. Patients already received bendamustine treatment. 12. Patients are inappropriate for rituximab treatment. 13. Patients have severe allergic symptoms. 14. Inadequate for clinical trial entry by the attending physicians.
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