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

Lymphoma, Non-Hodgkin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094848
• Other study ID #: TRM1-HM01
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2004
• Last updated: August 1, 2013
• Start date: June 2004
• Est. completion date: May 2007

Study information

• Verified date: August 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• TRAIL-R1 mAb (TRM-1; HGS-ETR1)

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Country where clinical trial is conducted

United States,