JPRN-jRCT2080220744未知2 期
Phase II study of KW-0761 in subjects with CCR4-positive adult T-cell leukemia-lymphoma
Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 25 人开始时间: 2009年6月9日最近更新:
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1: Positive for serum anti-HTLV-I antibody
- •2: Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
- •3: Positive for CCR4
- •4: Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
- •5: Received at least one prior chemotherapy
- •6: Only after 4 weeks had elapsed since the most recent treatment 4 weeks
- •7: PS of 0 to 2
- •8: Negative for HBs antigen and for HBV-DNA by a real-time PCR
排除标准
- •1: A history of transplantation such as hematopoietic stem cells
- •2: Positive for HCV antibody or HIV antibody
- •3: Active multiple cancers at the time of starting this clinical study
- •4: Previous history of allergic reactions after receiving antibody products
- •5: Requiring continuous systemic treatment with a steroid
- •6: Requiring such radiotherapy after starting this clinical study
- •7: Treated with any investigational drug other than KW-0761 within three months
研究者
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