NCT Number: NCT00094848
Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
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).
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Mayo Clinic, Rochester, Minnesota, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Human Genome Sciences Inc.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2004
- Primary completion
- 2006
- Study completion
- 2007
- First posted
- Oct 27, 2004
- Registry last updated
- Aug 2, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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