JPRN-UMIN000001603已完成2 期
A multicenter phase II open-label study in untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma evaluating efficacy and safety of maintenance therapy with IDEC-C2B8. - Japanese Phase II study for Rituximab Maintenance
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
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
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Treatment history i)With a history of other monoclonal antibody treatment. ii)Have participated in other clinical trial(s) for unapproved agent or treated with unapproved indication within 6 months prior to registration iii)Who received G-CSF within 7days prior to trial entry iv)With a history of sensitive or allergic to murine-derived materials v)Having received major surgery (excluding lymph node biopsy) within 28 days prior to registration 2)Follicular lymphoma Grade 3b 3)Tumor cells in peripheral blood > 10,000/uL 4)Co-existing medical conditions or previous disease i)Known HIV infection ii)Known active HBV or HCV infection and/or known positive in any one of HBs antigen, HBs antibody, HBc antibody or HCV antibody by laboratory tests within 28 days prior to registration 5)Patients with infections and serious underlying medical conditions which could impair the ability of the patient to participate in the trial 6)Patients who routinely use insulin by self injection. 7)Patients with prior or concomitant malignancies 8)Presence or history of CNS lymphoma infiltration 9)Serious psychological conditions 10)Women who are pregnant, breast feeding or positive of pregnant test. 11)Women and men who do not agree to use effective contraception during participation in the trial and for 12 months thereafter.
研究者
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