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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 is a Phase 3 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 304 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00406393
The ClinicalTrials.gov registry entry for NCT00406393 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sirolimus is the first listed.
NCT00406393 reports 0 study locations.
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.
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