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NCT01596218 · ClinicalTrials.gov registry record · Phase 1
Brentuximab Vedotin for Steroid Refractory GvHD
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01596218: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01596218 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596218, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved brentuximab vedotin for the treatment of GVHD. Currently, corticosteroids are the standard/first line of treatment for people with GVHD. However, some patients do not achieve a good response with steroids and other experience flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a weakening of the immune system. For this reason, there have been increased attempts by researchers to find other options for the treatment of Graft vs. Host Disease. Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD, but results from other research studies show that it could help slow the growth of your disease. In this research study, we are trying to determine the safest dose of brentuximab vedotin that can be given to patients with GVHD.
Primary Outcome
To define the maximum tolerated dose (MTD) of brentuximab vedotin when given as treatment for steroid-refractory acute GVHD
Interventions
- DRUG Brentuximab Vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT01596218 record still lists
NCT01596218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Brentuximab Vedotin is the first listed.
NCT01596218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596218 about?
NCT01596218 is a clinical study titled "Brentuximab Vedotin for Steroid Refractory GvHD". This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that r...
What is the current status of trial NCT01596218?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2012-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01596218?
The interventions under investigation include: Brentuximab Vedotin (DRUG).
Who is sponsoring clinical trial NCT01596218?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01596218's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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