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NCT03959241 · ClinicalTrials.gov registry record · Phase 3
TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)
A Phase 3 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 3
- Development phase
- 431
- Enrollment target
NCT03959241 is a Phase 3 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 431 participants.
The verdict
NCT03959241, a Phase 3 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 431 participants
- Enrollment target
Study Summary
1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus/methotrexate (Tac/MTX) versus post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) in the setting of reduced intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation. 1801: The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.
Interventions
- DRUG Tacrolimus
- DRUG Methotrexate
- PROCEDURE Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate
- PROCEDURE Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2022-09-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03959241
The ClinicalTrials.gov registry entry for NCT03959241 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 431 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 4 interventions - of which Tacrolimus is the first listed.
NCT03959241 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03959241 about?
NCT03959241 is a clinical study titled "TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)". 1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus/methotrexate (Tac/MTX) versus post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) in the setting of reduced in...
What is the current status of trial NCT03959241?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 431 participants. The study started on 2019-06-25. Estimated completion is 2022-09-19.
What interventions are being tested in trial NCT03959241?
The interventions under investigation include: Tacrolimus (DRUG), Methotrexate (DRUG), Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate (PROCEDURE), Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide (PROCEDURE).
Who is sponsoring clinical trial NCT03959241?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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