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Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma. Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma clinical trial. Participants frequently get the best healthcare available for their Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma  Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
For Condition: noncontiguous stage 2 mantle cell lymphoma,recurrent mantle cell lymphoma,contiguous stage 2 mantle cell lymphoma,stage 1 mantle cell lymphoma,stage 4 mantle cell lymphoma,stage 3 mantle cell lymphoma
Status: No longer recruiting
Sponsor(s): Swiss Institute for Applied Cancer Research ,
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Compare the event free survival of patients after induction with or without consolidation. III. Compare the tolerability of these two treatment regimens by these patients. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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 nonmelanomatous skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MicheleGhielmini, Study Chair, Swiss Institute for Applied Cancer Research
City Hospital Triemli
Zurich, , 8063
Switzerland
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Istituto Oncologico della Svizzera Italiana
Lugano, , CH-6900
Switzerland
Klinik Hirslanden
Zurich, , CH-8008
Switzerland
Kantonspital Aarau
AARAU, , 5001
Switzerland
Inselspital, Bern
BERN, , CH-3010
Switzerland
University Hospital
Basel, , CH-4031
Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, , CH-1211
Switzerland
Office of Walter Weber-Stadelman
Basel, , CH 4051
Switzerland
Burgerspital, Solothurn
Solothurn, , 4500
Switzerland
Additional Information:
Study ID Numbers: CDR0000066188; SWS-SAKK-35/98,EU-98009,ICR-35/98
Study Start Date: January 1998
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003280
Other Recurrent Mantle Cell Lymphoma Studies:
1. Bortezomib in Treating Patients With Mantle Cell Lymphoma
2. Rituximab and Cladribine in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
3. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
5. Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
Related Studies:
Other recurrent mantle cell lymphoma Clinical Trials
Other Clinical Trials
Other Solothurn Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
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