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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Keywords

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lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Interferon Gamma-1b

100 or 200 mcg, SQ, 3x per week

Intervention Type DRUG

Rituximab

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Williamson Bradford, MD

Role: STUDY_DIRECTOR

InterMune

Locations

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Intermune Inc

Brisbane, California, United States

Site Status

Countries

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United States

Other Identifiers

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GINHL-001

Identifier Type: -

Identifier Source: org_study_id