Status:
COMPLETED
Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- Primary
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00094848
Start Date
June 1 2004
End Date
May 1 2007
Last Update
August 2 2013
Active Locations (7)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
3
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
4
Memorial Sloan Kettering
New York, New York, United States, 10021