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| Sponsors and Collaborators: |
Arbeitsgemeinschaft medikamentoese Tumortherapie Hoffmann-La Roche |
|---|---|
| Information provided by: | Arbeitsgemeinschaft medikamentoese Tumortherapie |
| ClinicalTrials.gov Identifier: | NCT00400478 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
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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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| Contact: ulrich jaeger, prof dr | 43-14-0400 ext 4410 | ulrich.jaeger@meduniwien.ac.at |
| Contact: helen melzer, dr | 43-14-0400 ext 4410 | helen.melzer@meduniwien.ac.at |
Show 125 Study Locations| Principal Investigator: | Ulrich Jaeger, Prof. Dr. | Medical University of Vienna |
More Information
| Responsible Party: | AGMT ( Prof. Ulrich Jäger ) |
| Study ID Numbers: | NHL-13 (ML18223) |
| Study First Received: | November 16, 2006 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00400478 |
| Health Authority: | Austria: Ethikkommission |
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DLBCL NHL 13 Rituximab maintenance |
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Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab |
B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Aggression Lymphoma |
|
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |
