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NCT04131738 · ClinicalTrials.gov registry record · Phase 1
Baricitinib for the Prophylaxis of Graft-Versus-Host Disease After Peripheral Blood Hematopoietic Cell Transplantation
A Phase 1 study of Graft-Versus-Host Disease and Graft Vs Host Disease, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT04131738: Completed Phase 1 study of Graft-Versus-Host Disease and Graft Vs Host Disease, sponsored by Washington University School of Medicine.
NCT04131738 is a Phase 1 study of Graft-Versus-Host Disease and Graft Vs Host Disease that has completed, run by Washington University School of Medicine. The registered enrollment target is 26 participants, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04131738, a Phase 1 study of Graft-Versus-Host Disease and Graft Vs Host Disease, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
In this trial, the investigators will begin to explore the possibility that, as in mice, JAK1/2 inhibition with hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) while retaining engraftment and Graft-versus-Leukemia (GVL). Both preclinical and clinical data suggest that inhibition of IFNy and IL-6, directly and using downstream JAK Inhibitors, may be an effective strategy to decrease toxicities and improve disease control for patients undergoing Allogeneic HSCT. Baricitinib, as a JAK1/2 inhibitor, has shown superiority to other JAK inhibitors in preclinical GVHD models. The purpose of this phase I clinical trial is to determine the safety of baricitinib with HSCT measured by the effect on engraftment and grade III-IV acute graft-versus-host-disease (aGVHD).
Primary Outcome
-Failure to engraft will be defined as failure to achieve absolute neutrophil count \> 500 for 3 days by Day 28.
Conditions Studied
Interventions
- DRUG Baricitinib
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-04-07 |
| Est. Completion | 2022-08-17 |
| Phase | Phase 1 |
What the finished NCT04131738 record still lists
NCT04131738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Baricitinib is the first listed.
NCT04131738 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04131738 about?
NCT04131738 is a clinical study titled "Baricitinib for the Prophylaxis of Graft-Versus-Host Disease After Peripheral Blood Hematopoietic Cell Transplantation". In this trial, the investigators will begin to explore the possibility that, as in mice, JAK1/2 inhibition with hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) while retaining engraftment and Graft-versus-Leukemia (GVL). Both preclinical and clinical data sugge...
What is the current status of trial NCT04131738?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-04-07. Estimated completion is 2022-08-17.
What conditions does trial NCT04131738 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease, Graft Vs Host Disease.
What interventions are being tested in trial NCT04131738?
The interventions under investigation include: Baricitinib (DRUG).
Who is sponsoring clinical trial NCT04131738?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04131738 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04131738's enrollment target sits among peer trials
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