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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

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 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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

TRM1-HM01

NCT ID:

NCT00094848

Start Date:

June 2004

Completion Date:

May 2007

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Memorial Sloan KetteringNew York, New York  10021
Sarah Cannon Research InstituteNashville, Tennessee  37203