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NCT00406393 · ClinicalTrials.gov registry record · Phase 3
Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
A Phase 3 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
NCT00406393: Completed Phase 3 study, sponsored by Medical College of Wisconsin.
NCT00406393 is a Phase 3 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 304 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00406393, a Phase 3 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
Study Summary
The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.
Primary Outcome
The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.
Interventions
- DRUG Sirolimus
- DRUG Tacrolimus
- DRUG Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2006-11 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT00406393 record still lists
NCT00406393 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Sirolimus is the first listed.
NCT00406393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00406393 about?
NCT00406393 is a clinical study titled "Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)". The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell tr...
What is the current status of trial NCT00406393?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2006-11. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00406393?
The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT00406393?
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 NCT00406393's enrollment target sits among peer trials
304 1117th of 2000 higher than 882 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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