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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00363636 |
This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL.
The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin's |
Drug: Galiximab in combination with rituximab Drug: Rituximab in combination with placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 742 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Galiximab in combination with rituximab
Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
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2: Active Comparator |
Drug: Rituximab in combination with placebo
Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Inclusion Criteria:
Key Exclusion Criteria:
Contact: Biogen Idec | oncologyclinicaltrials@biogenidec.com |
Study Director: | Biogen Idec | Biogen Idec |
Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
Study ID Numbers: | 114-NH-301 |
Study First Received: | August 11, 2006 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00363636 |
Health Authority: | United States: Food and Drug Administration |
NHL relapsed refractory antibody rituximab |
galiximab efficacy safety pharmacokinetics |
Lymphatic Diseases Antibodies Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |