Status:
TERMINATED
Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Chiron Corporation
Conditions:
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treat...
Eligibility Criteria
Inclusion
- CD20+ follicular B-cell non-hodgkin's lymphoma with at least 1 site of measurable disease.
- Previous treatment with 1 to 4 prior chemotherapy regimens
- ECOG performance status of greater than or equal to 2
- Life expectancy of greater than 18 weeks
- Meet safety lab requirements and organ function tests
Exclusion
- Prior treatment with rituximab or IL-2
- Prior radioimmunotherapy including Zevalin or Bexxar
- 5 or more prior chemotherapy regimens
- Clinically significant cardiac disease, lung dysfunction, autoimmune disease, thyroid disease, active infection, unstable psychiatric condition, or HIV infection.
- History of allogenic bone marrow transplant
- Female subjects that are pregnant or breast feeding
- Immunosuppressive therapy including corticosteroids or investigational agents within 4 weeks prior to the planned start of study treatment
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00100737
Last Update
February 6 2006
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263