Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients
Information source: InterMune
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Hodgkin's Lymphoma
Intervention: Interferon Gamma-1b (Drug); Rituximab (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: InterMune Official(s) and/or principal investigator(s):
Williamson Bradford, MD, Study Director, Affiliation: InterMune
Summary
Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b
(IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with
progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)
International study with sites in the Czech Republic and Poland
Clinical Details
Official title: Phase I/II Study of the Safety of Subcutaneous Interferon Gamma-1b Combined With Rituximab in Patients With Low Grade/Follicular Non-Hodgkin's Lymphoma
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
- Relapsed or progressive low-grade/follicular NHL who are candidates for rituximab
therapy
- Patients who were on other therapy including CHOP or radiation
- Previous therapy must have concluded 30 days prior to enrollment
- Demonstrable CD20-positive tumor population in lymph nodes or bone marrow
Locations and Contacts
Intermune Inc, Brisbane, California 94005, United States
Additional Information
Starting date: March 2003
Ending date: June 2004
Last updated: October 30, 2007
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