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OpenTrials
Completed

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic, Rochester, Minnesota, United States

Loading trial locations.

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

TRAIL-R1 mAb (TRM-1; HGS-ETR1)

Drug

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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