Lymphoma, Non-HodgkinPhase 2NCT00094848
Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study testing TRAIL-R1 mAb (TRM-1; HGS-ETR1) in people with Lymphoma, Non-Hodgkin, run by Human Genome Sciences Inc. at 7 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- TRAIL-R1 mAb (TRM-1; HGS-ETR1)
- How many people
- Not given
- Where
- 7 sitesUnited States
- Study dates
- Jun 2004to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
MD Anderson Cancer Center
Houston, Texas, 77230
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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
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).
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- TRAIL-R1 mAb (TRM-1; HGS-ETR1)
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAIL-R1 mAb (TRM-1; HGS-ETR1)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2004 (estimated)
- Study startJun 2004
- Primary completionDec 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Human Genome Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094848
- Sponsor's protocol ID
- TRM1-HM01
- Status last verified
- Aug 2013
- First submitted
- 27 Oct 2004
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00094848
- Acronym / sponsor ID
- TRM1-HM01
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Human Genome Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 27 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAIL-R1 mAb (TRM-1; HGS-ETR1) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRAIL-R1 mAb (TRM-1; HGS-ETR1) in people with Lymphoma, Non-Hodgkin, run by Human Genome Sciences Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.