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Sponsors and Collaborators: |
Millennium Pharmaceuticals, Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00312845 |
The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: VELCADE Drug: Rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 670 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
VELCADE
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Drug: VELCADE
1.6 mg/m2 VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m2 rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of 375 mg/m2 rituximab on Day 1 of Cycles 2 to 5.
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2: Experimental
Rituximab
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Drug: Rituximab
375 mg/m2 rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose of 375 mg/m2 rituximab on Day 1 of Cycles 2 to 5 (for a total of 8 doses).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
If any prior regimen included rituximab, the subject must have responded (complete response [CR], unconfirmed complete response [CRu], partial response [PR]), and the time to progression (TTP) from the first dose of rituximab must have been 6 months or more.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
History of disallowed therapies:
Responsible Party: | Johnson and Johnson Pharmaceutical Research and Development Pharmaceuticals ( Clinical Research Monitor ) |
Study ID Numbers: | 26866138-LYM-3001 |
Study First Received: | April 7, 2006 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00312845 |
Health Authority: | United States: Food and Drug Administration |
B-cell Non-Hodgkin's Lymphoma |
Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders Rituximab B-cell lymphomas |
Bortezomib Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin 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 |