Back to resultsSafety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interferon Gamma-1b
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring lymphoma
Eligibility 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
Sites / Locations
- Intermune Inc
Outcomes
Primary Outcome Measures
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00057447
Brief Title
Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Why Stopped
administrative reasons
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
InterMune
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Interferon Gamma-1b
Intervention Description
100 or 200 mcg, SQ, 3x per week
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg per square meters, IV, 1x per week
Primary Outcome Measure Information:
Title
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Williamson Bradford, MD
Organizational Affiliation
InterMune
Official's Role
Study Director
Facility Information:
Facility Name
Intermune Inc
City
Brisbane
State/Province
California
ZIP/Postal Code
94005
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients
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