A Phase III, Randomized, Double-Blind Study of Galiximab in Combination with Rituximab Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non Hodgkin’s Lymphoma

Biogen Idec Ltd.0 个研究点目标入组 742 人2007年3月28日

概览

暂无简介。

注册库

who.int

开始日期

2007年3月28日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•To be considered for registration and randomization into this study, subjects must satisfy all of the following criteria:
•1\. Must give written informed consent and any authorizations as required by local law
•2\. Aged \=18 years old at the time of informed consent
•3\. Histologically confirmed follicular Grade 1\-3a NHL. If slides and/or tissue blocks
•from the most recent lymph biopsy are not available for Central Pathology Review, a
•repeat lymph node biopsy is required prior to enrollment. If there is any clinical
•evidence suggesting transformation (e.g. elevated LDH \>2× upper limit of normal),
•a biopsy is required within 6 months prior to enrollment. Subjects with evidence of
•histologic transformation on a repeat biopsy are excluded from this study.
•4\. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment as determined by one of the following:

•Unless otherwise specified, candidates will be excluded from study entry if any of the
•following exclusion criteria exist at the time of randomization:
•1\. Follicular lymphoma Grade 3b
•2\. Previous exposure to galiximab or any anti\-CD80 antibody
•3\. Known hypersensitivity to murine proteins
•4\. Rituximab refractory or refractory to anti\-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab\-containing regimen, or a response with a TTP of less than 6 months)
•5\. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to
•Study Day 1 (6 weeks if nitrosourea or mitomycin\-C)
•6\. Prior lymphoma vaccine therapy within 12 months prior to Study Day 1
•7\. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1