A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00269113
First received: December 22, 2005
Last updated: July 15, 2009
Last verified: July 2009
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Purpose
This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: rituximab [MabThera/Rituxan] Drug: Standard chemotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label Study of the Effect of MabThera Plus Chemotherapy Versus Chemotherapy Alone on Clinical Response in Patients With Indolent Non-Hodgkin's and Mantle Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Clinical response (complete or partial remission). [ Time Frame: After 8 months of treatment ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse drug effects, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 368 |
| Study Completion Date: | April 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv monthly for 8 cycles
Drug: Standard chemotherapy
As prescribed
|
| Active Comparator: 2 |
Drug: Standard chemotherapy
As prescribed
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients >=18 years of age;
- advanced, low-grade non-Hodgkin's and mantle cell lymphoma.
Exclusion Criteria:
- possibility of curative radiation therapy;
- secondary NHL;
- participation in another clinical trial eg with cytostatic chemotherapy or cytokines;
- concomitant diseases and/or restricted organ function precluding therapy according to the study protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269113
Locations
| Germany | |
| Berlin, Germany, 13122 | |
| Berlin, Germany, 12200 | |
| Bochum, Germany, 44791 | |
| Bonn, Germany, 53127 | |
| Borna, Germany, 04552 | |
| Chemnitz, Germany, 09120 | |
| Cottbus, Germany, 03042 | |
| Dresden, Germany, 01307 | |
| Dresden, Germany, 01067 | |
| Dülmen, Germany, 48249 | |
| Erfurt, Germany, 99089 | |
| Frankfurt an der Oder, Germany, 15236 | |
| Greifswald, Germany, 17487 | |
| Güstrow, Germany, 18273 | |
| Halle, Germany, 06120 | |
| Halle, Germany, 06110 | |
| Jena, Germany, 07740 | |
| Jena, Germany, 07743 | |
| Leipzig, Germany, 04103 | |
| Leipzig, Germany, 04315 | |
| Magdeburg, Germany, 39130 | |
| Magdeburg, Germany, 39120 | |
| Marburg, Germany, 35043 | |
| Neubrandenburg, Germany, 17036 | |
| Nordhausen, Germany, 99734 | |
| Potsdam, Germany, 14467 | |
| Riesa, Germany, 01589 | |
| Rostock, Germany, 18055 | |
| Rostock, Germany, 18057 | |
| Schwerin, Germany, 19049 | |
| Stralsund, Germany, 18435 | |
| Trier, Germany, 54290 | |
| Zella-mehlis, Germany, 98544 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00269113 History of Changes |
| Other Study ID Numbers: | M39023 |
| Study First Received: | December 22, 2005 |
| Last Updated: | July 15, 2009 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013