A Phase 2 Randomized, Open-Label, Controlled Trial of the Addition of 8 Weeks SC Administration of Aldesleukin (Rh-Interleukin-2 [IL-2]) to 4 Weeks of IV Administration of Rituximab in the Treatment of Rituximab Naïve Subjects With Follicular Non-Hodgkin’s Lymphoma, Refractory or Relapsed After Previous Chemotherapy
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