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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
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

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 IncBrisbane, California  94005