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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00081861 |
Purpose
Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Avastin Drug: Rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of Avastin Plus Rituximab for Patients With Relapsed and Chemotherapy- or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma |
| Enrollment: | 13 |
| Study Start Date: | March 2004 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Avastin + Rituximab: Experimental |
Drug: Avastin
10 mg/kg given intravenously every 2 weeks for 4 doses.
Drug: Rituximab
375 mg/m^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Barbara Pro, MD | U.T. M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Barbara Pro, MD / Associate Professor ) |
| Study ID Numbers: | 2003-0520 |
| Study First Received: | April 23, 2004 |
| Results First Received: | March 5, 2009 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00081861 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Non-Hodgkin's Lymphoma B-Cell Lymphoma Lymphoma Avastin |
Bevacizumab Rituximab Rituxan |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Growth Substances Physiological Effects of Drugs Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |