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NCT00057447 Clinical Trial

Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00057447
Other study ID # GINHL-001
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received April 1, 2003
Last updated October 30, 2007
Start date March 2003
Est. completion date June 2004

Study information
Verified date October 2007
Source InterMune
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 24
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility - 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Interferon Gamma-1b
100 or 200 mcg, SQ, 3x per week
• Rituximab
375 mg per square meters, IV, 1x per week

Locations
Country Name City State
United States Intermune Inc Brisbane California

Sponsors (1)
Lead Sponsor Collaborator
InterMune

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes) 6 weeks
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