|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Hoffmann-La Roche Genentech |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00486759 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
| 1: Experimental |
Drug: bevacizumab [Avastin]
5mg/kg / week dosing equivalent iv
Drug: R-CHOP
As prescribed
|
| 2: Placebo Comparator |
Drug: R-CHOP
As prescribed
Drug: Placebo
iv/week
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Please reference Study ID Number: BO20603 | 973-235-5000 | |
| Contact: or | 800-526-6367 (FOR US ONLY) |
Show 247 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| 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 |
