A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00472420
First received: May 10, 2007
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle Cell Lymphoma |
Drug: rituximab [MabThera/Rituxan] Drug: First line chemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Complete and partial response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Event-free survival, progression-free survival, time to treatment failure. [ Time Frame: AEs, laboratory parameters. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 3 weeks
Drug: First line chemotherapy
As prescribed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- histologically-proven mantle cell lymphoma;
- previously untreated disease at stage II, III and IV, requiring therapy.
Exclusion Criteria:
- known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
- active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
- serious disorders interfering with full standard dosing chemotherapy;
- stage I disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472420
Contacts
| Contact: Please reference Study ID Number: ML20493 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Hungary | |
| Completed | |
| Budapest, Hungary, 1122 | |
| Recruiting | |
| Debrecen, Hungary, 4004 | |
| Active, not recruiting | |
| Gyor, Hungary, 9024 | |
| Recruiting | |
| Kaposvar, Hungary, 7400 | |
| Recruiting | |
| Miskolc, Hungary, 3529 | |
| Recruiting | |
| Szeged, Hungary, 6720 | |
| Completed | |
| Zalaegerszeg, Hungary, 8901 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00472420 History of Changes |
| Other Study ID Numbers: | ML20493 |
| Study First Received: | May 10, 2007 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Hungary: Ministry of Health |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013