Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
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Purpose
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which treatment regimen is more effective for lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of rituximab in treating patients who have follicular or mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Phase III Trial to Determine the Effect of Consolidation With Rituximab (IDEC C2B8-Mabthera) in Patients With CD20+ Follicular or Mantle Cell Lymphoma Having Received Induction Therapy With Rituximab Weekly x 4 |
| Estimated Enrollment: | 240 |
| Study Start Date: | January 1998 |
| Study Completion Date: | March 2002 |
| Primary Completion Date: | March 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Assess the clinical efficacy of consolidation treatment with rituximab in terms of response rate in patients with follicular (closed to accrual 9/18/00) or mantle cell lymphoma.
- Compare the event free survival of patients after induction with or without consolidation.
- Compare the tolerability of these two treatment regimens by these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to participating center, histology (follicular (closed to accrual 9/18/00) vs mantle cell), status of disease (de novo vs relapsed vs resistant), response after induction (stable disease vs partial or complete response), and treatment status (treated vs untreated).
All patients receive induction therapy consisting of rituximab IV over 3-5 hours once a week during weeks 1-4. Patients are then randomized to one of two treatment arms.
- Arm I: Patients are observed.
- Arm II: Patients receive rituximab IV over 3-5 hours once a week during weeks 12, 20, 28, and 36.
Patients are followed weekly for the first month; every 8 weeks for the next 8 months; then at 12, 18, and 24 months; and then annually for the next 3 years.
PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 3-4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven CD20 positive follicular (closed to accrual 9/18/00) or mantle cell lymphoma
- Untreated "de novo" disease OR
- Chemotherapy resistant disease OR
- Relapsing disease
- Bidimensionally measurable disease
- No symptomatic CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- No hepatitis B or C
Renal:
- Creatinine no greater than 2 times ULN
Cardiovascular:
- Ejection fraction at least 50%
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active opportunistic infections
- HIV negative
- No prior malignancy within 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior antibody based therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas) and recovered
- No concurrent chemotherapy
Endocrine therapy:
- At least 4 weeks since prior corticosteroids, unless chronic dose no greater than 20 mg/day for nonlymphoma related condition
- No other concurrent corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Contacts and Locations| Switzerland | |
| Kantonspital Aarau | |
| Aarau, Switzerland, 5001 | |
| University Hospital | |
| Basel, Switzerland, CH-4031 | |
| Office of Walter Weber-Stadelman | |
| Basel, Switzerland, CH 4051 | |
| Ospedale San Giovanni | |
| Bellinzona, Switzerland, CH-6500 | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Hopital Cantonal Universitaire de Geneva | |
| Geneva, Switzerland, CH-1211 | |
| Istituto Oncologico della Svizzera Italiana | |
| Lugano, Switzerland, CH-6900 | |
| Burgerspital, Solothurn | |
| Solothurn, Switzerland, 4500 | |
| City Hospital Triemli | |
| Zurich, Switzerland, 8063 | |
| Klinik Hirslanden | |
| Zurich, Switzerland, CH-8008 | |
| Study Chair: | Michele Ghielmini, MD | Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni |
More Information
Publications:
| Responsible Party: | Swiss Group for Clinical Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00003280 History of Changes |
| Other Study ID Numbers: | SAKK 35/98, SWS-SAKK-35/98, ICR-35/98, EU-98009 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Swiss Group for Clinical Cancer Research:
|
stage I mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma |
stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma |
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 21, 2013