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

Sponsor
Human Genome Sciences Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00094848
Collaborator
(none)
7
Locations
35
Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: TRAIL-R1 mAb (TRM-1; HGS-ETR1)
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905
    2 University of Nebraska Medical Center Omaha Nebraska United States 68198
    3 Roswell Park Cancer Institute Buffalo New York United States 14263
    4 Memorial Sloan Kettering New York New York United States 10021
    5 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    6 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    7 MD Anderson Cancer Center Houston Texas United States 77230

    Sponsors and Collaborators

    • Human Genome Sciences Inc.

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Human Genome Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT00094848
    Other Study ID Numbers:
    • TRM1-HM01
    First Posted:
    Oct 27, 2004
    Last Update Posted:
    Aug 2, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Mapatumumab

    Study Results

    No Results Posted as of Aug 2, 2013