Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

This study has been completed.

First Received on October 27, 2004. Last Updated on March 2, 2012 History of Changes

Sponsor:	Human Genome Sciences
Information provided by (Responsible Party):	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00094848

Purpose

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).

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin	Drug: TRAIL-R1 mAb (TRM-1; HGS-ETR1)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Study Start Date:	June 2004
Study Completion Date:	May 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094848

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering
New York, New York, United States, 10021
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77230

Sponsors and Collaborators

Human Genome Sciences

More Information

No publications provided

Responsible Party:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00094848 History of Changes
Other Study ID Numbers:	TRM1-HM01
Study First Received:	October 27, 2004
Last Updated:	March 2, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2012