Back to resultsStudy of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TRAIL-R1 mAb (TRM-1; HGS-ETR1)
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin
Eligibility Criteria
Primary Inclusion Criteria: Relapsed or refractory histologically confirmed Non-Hodgkin's Lymphoma Previously treated with at least 1 therapeutic regimen and relapsed or progressed or failed to achieve a response after the last regimen 18 years of age or older Primary Exclusion Criteria: Received a non-FDA approved investigational agent within the last 4 weeks Received cancer therapies (chemotherapy, biological therapy [including hormonotherapy], radiation therapy or immunosuppressants within the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or nitrosourea Eligible for a hematopoietic stem cell transplant (HSCT) or have had an autologous HSCT within the last 16 weeks Prior history of an allogeneic HSCT HIV, AIDS-related lymphoma, central nervous system (CNS) lymphoma, Hepatitis-B or Hepatitis-C Infection requiring antibiotics within the last 4 weeks Major surgery within the last 4 weeks Pregnant or breast-feeding women History of other cancers within the past 5 years
Sites / Locations
- Mayo Clinic
- University of Nebraska Medical Center
- Roswell Park Cancer Institute
- Memorial Sloan Kettering
- Fox Chase Cancer Center
- Sarah Cannon Research Institute
- MD Anderson Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00094848
First Posted
October 27, 2004
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00094848
Brief Title
Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
Official Title
A Multi-Center, Open-Label, Dose-Escalation Study to Evaluate the Safety, Efficacy, and Exposure to TRM-1 (Fully Human Monoclonal Antibody to the TRAIL-R1) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TRAIL-R1 mAb (TRM-1; HGS-ETR1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria:
Relapsed or refractory histologically confirmed Non-Hodgkin's Lymphoma
Previously treated with at least 1 therapeutic regimen and relapsed or progressed or failed to achieve a response after the last regimen
18 years of age or older
Primary Exclusion Criteria:
Received a non-FDA approved investigational agent within the last 4 weeks
Received cancer therapies (chemotherapy, biological therapy [including hormonotherapy], radiation therapy or immunosuppressants within the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or nitrosourea
Eligible for a hematopoietic stem cell transplant (HSCT) or have had an autologous HSCT within the last 16 weeks
Prior history of an allogeneic HSCT
HIV, AIDS-related lymphoma, central nervous system (CNS) lymphoma, Hepatitis-B or Hepatitis-C
Infection requiring antibiotics within the last 4 weeks
Major surgery within the last 4 weeks
Pregnant or breast-feeding women
History of other cancers within the past 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77230
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
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