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

InterMune

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Rituximab; Drug: Interferon Gamma-1b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00057447

GINHL-001

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)