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

Stopped early · Phase 2

Conditions studied: Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT00100737

Run by

Chiron Corporation

People needed

300

Last updated by the study team

2006-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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