NCT00717925已完成1 期
A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 13 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.
研究概览
简要总结
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
- •Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma.
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
排除标准
- •Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article.
- •Patients must not have received bilateral pelvic irradiation.
- •Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.
研究组 & 干预措施
1
Experimental
干预措施: Inotuzumab Ozogamicin (CMC-544) (Drug)
结局指标
主要结局
Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.
时间窗: 4 months
次要结局
- Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas).(4 months)
研究者
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不适用
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进行中（未招募）
不适用
A Phase 2 Study of Inotuzumab Ozogamicin (CMC-544) in Patients with Indolent (slow-growing) Non-Hodgkin Lymphoma (a type of blood cancer) Who Have Failed Treament with Rituximab and Chemotherapy (a drug that prevents the growth of tumor cells) or Radioimmunotherapy(a drug that kills tumor cells with radiation)EUCTR2008-001635-34-DEWyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA81