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Sponsors and Collaborators: |
Genmab GlaxoSmithKline |
Information provided by: | Genmab |
ClinicalTrials.gov Identifier: | NCT00494780 |
To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP in previously untreated patients with Follicular Lymphoma
Condition | Intervention | Phase |
Follicular Lymphoma |
Drug: Ofatumumab |
Phase II |
MedlinePlus related topics: | Cancer Lymphoma |
Drug Information available for: | Tositumomab Sodium chloride Ofatumumab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Labeled, Randomized, Two-Dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma. |
Estimated Enrollment: | 56 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | November 2013 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
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Drug: Ofatumumab
ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given.
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2: Active Comparator
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
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Drug: Ofatumumab
ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |||||
Rush University Medical Center | |||||
Chicago, Illinois, United States, 60612 | |||||
United States, New York | |||||
Roswell Park Cancer Institute | |||||
Buffalo, New York, United States, 14263 | |||||
United States, Ohio | |||||
Cleveland Clinic | |||||
Cleveland, Ohio, United States, 44195 | |||||
Czech Republic | |||||
University Hospital Motol | |||||
Prague, Czech Republic | |||||
University Hospital Hradec Kralove | |||||
Hradec Kralove, Czech Republic, 50005 | |||||
General Faculty Hospital, Charles University Prague | |||||
Prague, Czech Republic, 128 08 | |||||
University Hospital Bmo | |||||
Bmo, Czech Republic, 625 00 | |||||
Nemocnice Ceske Budejovice | |||||
Budejovice, Czech Republic, 370 87 | |||||
Denmark | |||||
Vejle Hospital | |||||
Vejle, Denmark, 7100 | |||||
Odense Universitets Hospital | |||||
Odense, Denmark, 5000 | |||||
Germany | |||||
Universitätsklinikum Ulm | |||||
Ulm, Germany, 89081 | |||||
Universitätsklinikum Essen | |||||
Essen, Germany, 45122 | |||||
Universitätsklinikum Göttingen | |||||
Göttingen, Germany, 37075 | |||||
Johannes Gutenberg University | |||||
Mainz, Germany, 55101 | |||||
Sweden | |||||
University Hospital in Lund | |||||
Lund, Sweden, 221 85 |
Genmab |
GlaxoSmithKline |
Principal Investigator: | Myron Czuczman, Ass. Prof. M.D. | Roswell Park Cancer Institute |
Responsible Party: | Genmab A/S ( Genmab A/S ) |
Study ID Numbers: | Hx-CD20-409 |
First Received: | June 29, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00494780 |
Health Authority: | United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Czech Republic: State Institute for Drug Control |
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