Status:
COMPLETED
Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Lead Sponsor:
Biogen
Conditions:
Lymphoma, Non-Hodgkin
Lymphoma, Low-Grade
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 31 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00168727
Start Date
June 1 2003
End Date
October 31 2005
Last Update
August 23 2023
Active Locations (8)
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1
Loma Linda University
Loma Linda, California, United States
2
North County Oncology
Oceanside, California, United States
3
Medical Specialists of Fairfield
Fairfield, Connecticut, United States
4
Queens Hospital
Honolulu, Hawaii, United States