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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00430352 |
Purpose
This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: rituximab [MabThera/Rituxan] |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy. |
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | March 2011 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 8 weeks
|
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
Show 178 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: | MO19872 |
| Study First Received: | January 31, 2007 |
| Last Updated: | June 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00430352 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Follicular |
Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Follicular Lymphoma Lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Lymphoma, Follicular |
Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |