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

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

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00057447
Enrollment
24
Registered
2003-04-03
Start date
2003-03-31
Completion date
2004-06-30
Last updated
2007-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Keywords

lymphoma

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

Interventions

DRUGInterferon Gamma-1b

100 or 200 mcg, SQ, 3x per week

DRUGRituximab

375 mg per square meters, IV, 1x per week

Sponsors

InterMune
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026