EUCTR2008-006035-12-GB进行中（未招募）1 期
A Phase 2 study of SGN-35 in treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL)
Seattle Genetics, Inc.0 个研究点目标入组 58 人开始时间: 2009年5月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
入选标准
- •Patients with relapsed or refractory systemic ALCL (anaplastic large cell lymphoma) who have previously received front line chemotherapy.
- •Documented anaplastic lymphoma kinase (ALK) status.
- •Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
- •Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
- •Received any previous ASCT (autologous stem cell transplant) at least 12 weeks (3 months) prior.
- •At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Previous treatment with SGN-35.
- •Previously received an allogeneic transplant.
- •Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
- •Known cerebral/meningeal disease.
研究者
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