Clinical Trial: Study of TRM-1 (TRAIL-R1 monoclonal antibody) in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)


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Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences

Condition	Treatment or Intervention	Phase
Lymphoma, Non-Hodgkin	Drug: TRAIL-R1 mAb (TRM-1; HGS-ETR1)	Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Primary Inclusion Criteria:

Relapsed or refractory histologically confirmed Non-Hodgkin's Lymphoma
Previously treated with at least 1 therapeutic regimen and relasped 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

Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States; Not yet recruiting

Nebraska
University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States; Recruiting

New York
Roswell Park Cancer Institute, Buffalo, New York, 14263, United States; Recruiting

Memorial Sloan Kettering, New York, New York, 10021, United States; Recruiting

Pennsylvania
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States; Recruiting

Tennessee
Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States; Not yet recruiting

Texas
MD Anderson Cancer Center, Houston, Texas, 77230, United States; Recruiting

Study ID Numbers: TRM1-HM01
Record last reviewed: October 2004
Record first received: October 27, 2004
ClinicalTrials.gov Identifier: NCT00094848
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-16