Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
Phase 2
Completed
- Conditions
- Lymphoma, Non-Hodgkin
- Registration Number
- NCT00094848
- Lead Sponsor
- Human Genome Sciences Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Memorial Sloan Kettering
🇺🇸New York, New York, United States