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Sponsored by: |
Biogen Idec |
Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00168727 |
The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin’s Lymphoma (NHL) or relapsed Non-Hodgkin’s lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.
Condition | Intervention | Phase |
Lymphoma, Non-Hodgkin Lymphoma, Low-Grade |
Drug: ibritumomab tiuxetan (Zevalin®) |
Phase IV |
MedlinePlus related topics: | Lymphoma |
ChemIDplus related topics: | Rituximab Ibritumomab tiuxetan |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma |
Estimated Enrollment: | 12 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | October 2005 |
The objective of this study is to determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in patients with low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of Rituxan maintenance therapy in a multicenter, community-based setting, as well as evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.
To meet the initial trial enrollment goal of 300 patients over two years, 42 total sites were activated. The study has subsequently closed to accrual. Currently 8 sites remain active to follow the 12 subjects enrolled in the past year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Loma Linda University | |||||
Loma Linda, California, United States | |||||
North County Oncology | |||||
Oceanside, California, United States | |||||
United States, Connecticut | |||||
Medical Specialists of Fairfield | |||||
Fairfield, Connecticut, United States | |||||
United States, Hawaii | |||||
Queens Hospital | |||||
Honolulu, Hawaii, United States | |||||
United States, Illinois | |||||
Northwest Oncology and Hematology | |||||
Elk Grove Village, Illinois, United States | |||||
United States, Indiana | |||||
Horizon Oncolgy Center | |||||
Lafayette, Indiana, United States | |||||
United States, Missouri | |||||
Specialists in Hematology/Oncology | |||||
St. Louis, Missouri, United States | |||||
United States, North Carolina | |||||
Presbyterian Hospital Cancer Center | |||||
Charlotte, North Carolina, United States |
Biogen Idec |
Study Director: | Wayne Saville | Biogen Idec |
Study ID Numbers: | 001-03-ZEV, Former Biogen Idec: 106-I001 |
First Received: | September 13, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00168727 |
Health Authority: | United States: Food and Drug Administration |
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