NCT00057447TerminatedPhase 1
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
InterMune2 sites in 1 country24 target enrollmentStarted: March 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
Time Frame: 6 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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