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NCT05531786 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
A Phase 1 study of Graft Vs Host Disease, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT05531786: Recruiting Phase 1 study of Graft Vs Host Disease, sponsored by National Cancer Institute (NCI).
NCT05531786 is a Phase 1 study of Graft Vs Host Disease that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (64% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05531786, a Phase 1 study of Graft Vs Host Disease, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: Chronic graft-versus-host disease (cGVHD) is an immune system disorder that can occur in people who have had a stem cell transplant. cGVHD can affect multiple organs and increase risk of disability and death. New treatments are needed to treat cGVHD after stem cell transplant. Objective: To test a drug (pacritinib) in people with moderate or severe cGVHD that has not responded to previous treatment. Eligibility: People aged 18 years and older with moderate or severe cGVHD that has not responded to 2 or more lines of previous treatment. Design: Participants will be screened. They will have blood and urine tests. They will have tests of their heart and lung function. They may also have a CT scan. Some may have other specialized tests. Participants will take the study drug at home every day. Pacritinib is a capsule taken by mouth. The study doctor will determine the dosage and schedule. Participants will keep a medication diary. They will record the date and time of each drug dose and any missed doses. Participants will visit the clinic every 2 weeks for the first 4 months. Then they will visit the clinic once every 4 weeks. They will have blood and urine tests. During some visits, other screening tests will be repeated, and participants will fill out questionnaires about their quality of life. Photographs may be taken of skin rashes and joints affected by cGVHD. Participants will give saliva samples. Optional biopsies may be taken of the skin and mouth. Participants will take pacritinib for 6 to 12 months if no side effects develop. Follow-up visits will continue for up to 2 years. ...
Primary Outcome
grades and types of toxicity reported at each dose level. The overall estimate of the fraction of patients who have a DLT at the MTD will be reported.
Conditions Studied
Interventions
- DRUG Pacritinib
Study Locations (2)
Florida
- University of Miami - Miami
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2027-07-22 |
| Phase | Phase 1 |
What NCT05531786 shows while recruiting
NCT05531786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Graft Vs Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Pacritinib is the first listed.
NCT05531786 reports a single indexed study location in Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT05531786 about?
NCT05531786 is a clinical study titled "Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)". Background: Chronic graft-versus-host disease (cGVHD) is an immune system disorder that can occur in people who have had a stem cell transplant. cGVHD can affect multiple organs and increase risk of disability and death. New treatments are needed to treat cGVHD after stem cell transplant. Objectiv...
What is the current status of trial NCT05531786?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2023-03-06. Estimated completion is 2027-07-22.
What conditions does trial NCT05531786 study?
This clinical trial studies the following conditions: Graft Vs Host Disease.
What interventions are being tested in trial NCT05531786?
The interventions under investigation include: Pacritinib (DRUG).
Who is sponsoring clinical trial NCT05531786?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05531786 being conducted?
This trial has 2 study locations across Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05531786's enrollment target sits among peer trials
50 17th of 36 higher than 20 of 36 other Graft Vs Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft Vs Host Disease 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.
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