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

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ClinicalTrials.gov Identifier: NCT00057447
Recruitment Status : Terminated (administrative reasons)
First Posted : April 3, 2003
Last Update Posted : November 1, 2007
Sponsor:
Information provided by:
InterMune

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


Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Interferon Gamma-1b Drug: Rituximab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2003
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma


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


Primary Outcome Measures :
  1. time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes) [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057447


Locations
United States, California
Intermune Inc
Brisbane, California, United States, 94005
Sponsors and Collaborators
InterMune
Investigators
Study Director: Williamson Bradford, MD InterMune

ClinicalTrials.gov Identifier: NCT00057447     History of Changes
Other Study ID Numbers: GINHL-001
First Posted: April 3, 2003    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by InterMune:
lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Interferons
Interferon-gamma
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents