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NCT03605927 · ClinicalTrials.gov registry record · Phase 1
CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03605927: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03605927 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03605927, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the safety and efficacy of the addition of BMS-986004 to standard of care Sirolimus (SIR)-based immune suppression.
Primary Outcome
Cumulative incidence of grade II-IV acute graft-versus-host disease (GVHD) by day 100 after hematopoietic cell transplantation (HCT). Acute GVHD severity will be determined by standard Consensus Criteria, and the cumulative incidence of grade II-IV acute GVHD will be reported through day 100 post-HCT, with relapse and death as competing risk events.
Interventions
- DRUG Sirolimus
- DRUG Tacrolimus
- DRUG BMS-986004
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-02-15 |
| Est. Completion | 2023-07-25 |
| Phase | Phase 1 |
What the finished NCT03605927 record still lists
NCT03605927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 3 interventions - of which Sirolimus is the first listed.
NCT03605927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03605927 about?
NCT03605927 is a clinical study titled "CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease". The purpose of this study is to examine the safety and efficacy of the addition of BMS-986004 to standard of care Sirolimus (SIR)-based immune suppression.
What is the current status of trial NCT03605927?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2019-02-15. Estimated completion is 2023-07-25.
What interventions are being tested in trial NCT03605927?
The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), BMS-986004 (DRUG).
Who is sponsoring clinical trial NCT03605927?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03605927's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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