- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168727
Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Loma Linda, California, United States
- Loma Linda University
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Oceanside, California, United States
- North County Oncology
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Connecticut
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Fairfield, Connecticut, United States
- Medical Specialists of Fairfield
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Hawaii
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Honolulu, Hawaii, United States
- Queens Hospital
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Illinois
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Elk Grove Village, Illinois, United States
- Northwest Oncology and Hematology
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Indiana
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Lafayette, Indiana, United States
- Horizon Oncolgy Center
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Missouri
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Saint Louis, Missouri, United States
- Specialists in Hematology/Oncology
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North Carolina
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Charlotte, North Carolina, United States
- Presbyterian Hospital Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Follicular non-Hodgkin's lymphoma including SLL in first or second relapse.
- No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory.
- Age >= 18 years, not pregnant or lactating.
- Expected survival >= 3 mths; PS 0, 1, or 2.
- ANC >= 1,500/mm3, platelet counts >= 100,000/mm3.
- Total bilirubin > 2.0 mg/dL, creatinine > 2.0 mg/dL.
- Total lymphocyte count < 5,000/mm3 for SLL.
- <25% bone marrow involvement with lymphoma.
Exclusion Criteria:
- Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection.
- Bulky areas of disease more than 10 cm in diameter.
- Patients with CLL, CNS, or mantle cell lymphoma.
- Hx of HIV/AIDS related lymphoma, hepatitis B or C.
- Prior radioimmunotherapy or XRT to >25% of active bone marrow.
- G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wayne Saville, Biogen
Study record dates
Study Major Dates
Study Start (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001-03-ZEV
- Former Biogen Idec: 106-I001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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