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NCT01106833 · ClinicalTrials.gov registry record · Phase 2
Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
NCT01106833: Completed Phase 2 study, sponsored by Medical College of Wisconsin.
NCT01106833 is a Phase 2 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 151 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01106833, a Phase 2 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
Study Summary
This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.
Primary Outcome
Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death.
Interventions
- DRUG Sirolimus + calcineurin inhibitor + prednisone
- DRUG Sirolimus + prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2010-04 |
| Est. Completion | 2018-06 |
| Phase | Phase 2 |
What the finished NCT01106833 record still lists
NCT01106833 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 2 interventions - of which Sirolimus + calcineurin inhibitor + prednisone is the first listed.
NCT01106833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01106833 about?
NCT01106833 is a clinical study titled "Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)". This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be ra...
What is the current status of trial NCT01106833?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2010-04. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01106833?
The interventions under investigation include: Sirolimus + calcineurin inhibitor + prednisone (DRUG), Sirolimus + prednisone (DRUG).
Who is sponsoring clinical trial NCT01106833?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01106833's enrollment target sits among peer trials
151 454th of 2000 higher than 1,546 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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