Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiron Corporation
• Treatments: Interleukin-2; Rituximab

Criteria

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