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NCT00815919 · ClinicalTrials.gov registry record · Phase 2
Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00815919: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00815919 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00815919, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the effectiveness of bortezomib (Velcade) plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this drug combination in this patient population. Chronic GVHD is a medical condition that may occur after allogeneic stem cell transplantation. The donor's immune system may recognize the participants body (the host) as foreign and attempt to "reject" it. Bortezomib has been used in other research studies, and information from those studies suggests that this drug may help to control the abnormal immune responses that underlie cGVHD.
Primary Outcome
Participants had their cGVHD evaluated per NIH consensus criteria: Complete response: resolution of all reversible manifestations of cGVHD. Partial response: a decrease ≥ 1 point on a 3-point organ-specific scale or 2 points or more on a 10-point global scale without progression in any organ sites. Stable disease: no evidence of cGVHD response without evidence of progressive cGVHD. Progressive cGVHD: increase of ≥ 1 point on an organ-specific 3-point scale, addition of a new immunosuppressiv
Interventions
- DRUG Prednisone
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT00815919 record still lists
NCT00815919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Prednisone is the first listed.
NCT00815919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00815919 about?
NCT00815919 is a clinical study titled "Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease". The purpose of this research study is to determine the effectiveness of bortezomib (Velcade) plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this drug combination in this patient population. Chronic GVHD is a medical condition that may occur after allogeneic ...
What is the current status of trial NCT00815919?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2008-12. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00815919?
The interventions under investigation include: Prednisone (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT00815919?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00815919's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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