Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)
Phase 2
Terminated
- Conditions
- Non-Hodgkin Lymphoma
- Registration Number
- NCT00100737
- Lead Sponsor
- Chiron Corporation
- 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 treatment of follicular NHL subjects that have never received rituximab as a treatment and are refractory or relapsed after previous chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Roswell Park Cancer Institute🇺🇸Buffalo, New York, United States