NCT00094848

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2004

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

October 27, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2013

Enrollment Period

2.5 years

First QC Date

October 27, 2004

Last Update Submit

August 1, 2013

Conditions

Lymphoma, Non-Hodgkin

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering

New York, New York, 10021, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77230, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

mapatumumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2004

First Posted

October 27, 2004

Study Start

June 1, 2004

Primary Completion

December 1, 2006

Study Completion

May 1, 2007

Last Updated

August 2, 2013

Record last verified: 2013-08

Locations

US(7)