EUCTR2005-003836-22-SK
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed or Refractory, Follicular Non-Hodgkin’s Lymphoma
- Sponsor
- Biogen Idec Ltd.
- Enrollment
- 700
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 NHL Grade 1\-3a (if the subject has received any intervening lymphoma therapy since the most recent biopsy, a repeat biopsy will be required to exclude transformation)
- •4\. Relapsed or progressive disease after at least 1 chemotherapy requiring treatment as determined by one of the following:
- •\- Documented disease progression by CT scan using the International Workshop Response Criteria (IWRC) as described in protocol Appendix C
- •\- The presence of B symptoms
- •\- Bulky disease (at least 1 lesion \>5 cm)
- •\- Laboratory abnormalities (cytopenias)
- •\- Presence of masses which are causing ongoing clinical symptoms
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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