NCT00057447

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

April 1, 2003

Last Update Submit

October 30, 2007

Conditions

Non-Hodgkin's Lymphoma

Keywords

lymphoma

Outcome Measures

Primary Outcomes (1)

  • time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)

    6 weeks

Interventions

Interferon Gamma-1bDRUG

100 or 200 mcg, SQ, 3x per week

RituximabDRUG

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Intermune Inc

Brisbane, California, 94005, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma

Interventions

interferon gamma-1bRituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Williamson Bradford, MD

    InterMune

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2003

First Posted

April 3, 2003

Study Start

March 1, 2003

Study Completion

June 1, 2004

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

US(1)