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Sponsors and Collaborators: |
Arbeitsgemeinschaft medikamentoese Tumortherapie Hoffmann-La Roche |
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Information provided by: | Arbeitsgemeinschaft medikamentoese Tumortherapie |
ClinicalTrials.gov Identifier: | NCT00400478 |
This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.
Condition | Intervention | Phase |
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Diffuse Large B-Cell Lymphoma (DLBCL) Follicular NHL Grade 3b |
Drug: Rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-Cell Lymphoma: NHL-13 |
Estimated Enrollment: | 600 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Treatment
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Drug: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
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B: No Intervention
Observation
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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:
Principal Investigator: | Ulrich Jaeger, Prof. Dr. | Medical University of Vienna |
Responsible Party: | AGMT ( Prof. Ulrich Jäger ) |
Study ID Numbers: | NHL-13 (ML18223) |
Study First Received: | November 16, 2006 |
Last Updated: | January 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00400478 History of Changes |
Health Authority: | Austria: Ethikkommission |
DLBCL NHL 13 Rituximab maintenance |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, B-Cell Lymphatic Diseases B-cell Lymphomas |
Aggression Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, Large-cell Antirheumatic Agents Lymphoma |
Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |