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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00719472 |
This is a prospective, open-label, Phase III, multicenter, single-arm trial designed to assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of rituximab in previously untreated patients with DLBCL and follicular NHL. Approximately 385 patients will be enrolled at approximately 100 centers in the United States in order to achieve at least 350 evaluable patients.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase III Multicenter, Open-Label Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 385 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: rituximab
Intravenous repeating dose
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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:
Patients who meet any of the following criteria will be excluded from further study participation after Cycle 1:
Study Director: | Jamie Hirata, PharmD | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | U4391g |
Study First Received: | July 18, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00719472 |
Health Authority: | United States: Food and Drug Administration |
Follicular NHL NHL Large B-Cell NHL |
Lymphatic Diseases Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |