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
Phase 1/Phase 2
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma
Both
Non-Hodgkin's Lymphoma
Trial Information
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
Outcome Time Frame:
6 weeks
Principal Investigator
Williamson Bradford, MD
Investigator Role:
Study Director
Investigator Affiliation:
InterMune
Authority:
United States: Food and Drug Administration
Study ID:
GINHL-001
NCT ID:
NCT00057447
Start Date:
March 2003
Completion Date:
June 2004
Related Keywords:
- Non-Hodgkin's Lymphoma
- lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Intermune Inc | Brisbane, California 94005 |
