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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: Completed Phase 3 study, sponsored by Medical College of Wisconsin.
NCT03959241 is a Phase 3 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 431 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint is GRFS as a time to event endpoint from randomization. All randomized patients will be followed for one year; however, the primary endpoint will be analyzed as a time to event endpoint. The primary analysis will be done using the randomized population. An event for this time to event outcome is defined as grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause, whichever comes first. Time to event an
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 |
What the finished NCT03959241 record still lists
NCT03959241 is an interventional study that assigns participants to a tested intervention. The registered 431 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 (44% lower).
The record links to 0 conditions, and to 4 interventions - of which Tacrolimus is the first listed.
NCT03959241 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03959241's enrollment target sits among peer trials
431 877th of 2000 higher than 1,124 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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