Back to resultsZevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ibritumomab tiuxetan (Zevalin®)
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Radioimmunotherapy, Antigens, CD20
Eligibility Criteria
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
Sites / Locations
- Loma Linda University
- North County Oncology
- Medical Specialists of Fairfield
- Queens Hospital
- Northwest Oncology and Hematology
- Horizon Oncolgy Center
- Specialists in Hematology/Oncology
- Presbyterian Hospital Cancer Center
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00168727
Brief Title
Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Official Title
Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2003 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 31, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade
Keywords
Radioimmunotherapy, Antigens, CD20
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ibritumomab tiuxetan (Zevalin®)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Saville
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
Country
United States
Facility Name
North County Oncology
City
Oceanside
State/Province
California
Country
United States
Facility Name
Medical Specialists of Fairfield
City
Fairfield
State/Province
Connecticut
Country
United States
Facility Name
Queens Hospital
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Northwest Oncology and Hematology
City
Elk Grove Village
State/Province
Illinois
Country
United States
Facility Name
Horizon Oncolgy Center
City
Lafayette
State/Province
Indiana
Country
United States
Facility Name
Specialists in Hematology/Oncology
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Presbyterian Hospital Cancer Center
City
Charlotte
State/Province
North Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
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