Non Hodgkin Lymphoma Clinical Trial

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

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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.

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Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

300

Study ID:

NCT00100737

Recruitment Status:

Terminated

Sponsor:

Chiron Corporation

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

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Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

300

Study ID:

NCT00100737

Recruitment Status:

Terminated

Sponsor:


Chiron Corporation

How clear is this clinincal trial information?

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