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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00085696 |
The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.
Condition | Intervention | Phase |
---|---|---|
B-Cell Lymphoma Follicular Lymphoma Marginal Lymphoma |
Drug: VELCADE and rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of B-cell lymphoma (CD20+) of
Exclusion Criteria:
United States, California | |
UCLA School of Medicine | |
Los Angeles, California, United States, 90095 | |
United States, Florida | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
United States, Georgia | |
Georgia Cancer Specialists | |
Marietta, Georgia, United States, 30060 | |
Emory University Cancer Institute, Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
Midwest Cancer Research Group | |
Skokie, Illinois, United States, 60077 | |
United States, Kansas | |
Cancer Center of Kansas | |
Wichita, Kansas, United States, 67214 | |
United States, Missouri | |
Oncology/Henmatology Associates of Kansas City | |
Kansas City, Missouri, United States, 64111 | |
United States, Ohio | |
Mid Ohio Oncology/Hematology Inc. | |
Columbus, Ohio, United States, 43213 | |
United States, South Carolina | |
Charleston Cancer Center | |
Charleston, South Carolina, United States, 29406 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah, Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 | |
United States, Virginia | |
FNVHO - US Oncology | |
Fairfax, Virginia, United States, 20031 |
Study ID Numbers: | M34103-061 |
Study First Received: | June 11, 2004 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00085696 |
Health Authority: | United States: Food and Drug Administration |
Lymphoma Non-Hodgkin's NHL B-Cell Indolent |
Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders Rituximab B-cell lymphomas Bortezomib |
Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Antirheumatic Agents Pharmacologic Actions Protease Inhibitors |