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 55 人开始时间: 2008年12月11日最近更新: 2016年8月8日

研究概览

暂无简介。

•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

•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.

发起方

Seattle Genetics, Inc.