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Sponsors and Collaborators: |
Hoffmann-La Roche Genentech |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00486759 |
This 2 arm study will compare the efficacy and safety of Avastin in combination with MabThera and CHOP chemotherapy (RA-CHOP) versus MabThera plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients will be randomized to 8 cycles of treatment with R-CHOP plus Avastin, or R-CHOP plus placebo. The treatment with Avastin/Placebo and R-CHOP will be given either as a 2 weekly or 3 weekly schedule, and Avastin will be given at a weekly average dose of 5mg/kg (10mg/kg for 2 weekly cycles and 15mg/kg for 3 weekly cycles). Responding patients will continue on Avastin monotherapy (15mg/kg every 3 weeks) for up to 1 year. The anticipated time on treatment is 3-12 months, and the target sample size is 500+ individuals.
Condition | Intervention | Phase |
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Lymphoma, B-Cell |
Drug: bevacizumab [Avastin] Drug: R-CHOP Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Placebo-Controlled Study Comparing the Effect of Avastin in Combination With MabThera Plus CHOP, and MabThera Plus CHOP Alone, on Progression-Free Survival in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma. |
Estimated Enrollment: | 1060 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2015 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: bevacizumab [Avastin]
5mg/kg / week dosing equivalent iv
Drug: R-CHOP
As prescribed
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2: Placebo Comparator |
Drug: R-CHOP
As prescribed
Drug: Placebo
iv/week
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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:
Contact: Please reference Study ID Number: BO20603 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BO20603 |
Study First Received: | June 14, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00486759 |
Health Authority: | United States: Food and Drug Administration |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab |
B-cell lymphomas Disease Progression Bevacizumab Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |