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NCT07025538 · ClinicalTrials.gov registry record · Phase 1
Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation
A Phase 1 study, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT07025538: Recruiting Phase 1 study, sponsored by City of Hope Medical Center.
NCT07025538 is a Phase 1 study that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07025538, a Phase 1 study, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This phase I trial studies how well biomarker-guided ruxolitinib works for the prevention of chronic graft versus host disease (GVHD) in patients that have undergone allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is the most effective therapy for patients with high-risk blood and bone marrow malignancies. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. In chronic GVHD (cGVHD), symptoms occur more than three months after transplantation. Despite significant advances in how allogeneic HCTs are conducted, cGHVD remains a major limitation to the long-term success of the transplant and can impact patients' quality of life post-transplant. Checking GVHD biomarkers in patients' blood after allogeneic HCT may help doctors predict how likely the patient is to develop cGVHD. This information can be used to help guide patients with high levels to receive cGVHD preventative therapy with ruxolitinib. Ruxolitinib works by blocking some of the enzymes that are needed for the development of cGVHD, which may be an effective way to prevent cGVHD in patients with high levels of GVHD biomarkers.
Primary Outcome
UT in a given patient will be defined as any of the following that are assigned an attribution level of at least possibly related to ruxolitinib administration. 1) Any grade 3 or higher non-hematological adverse events, per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 toxicity criteria that last more than 5 days. 2) Prolonged myelosuppression, defined as ≥ grade 4 neutropenia or thrombocytopenia that persists for more than 7 days. 3) Hy's
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- OTHER Best Practice
- DRUG Ruxolitinib
- OTHER Biomarker Analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2028-06-22 |
| Phase | Phase 1 |
What NCT07025538 shows while recruiting
NCT07025538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07025538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07025538 about?
NCT07025538 is a clinical study titled "Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation". This phase I trial studies how well biomarker-guided ruxolitinib works for the prevention of chronic graft versus host disease (GVHD) in patients that have undergone allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is the most effective therapy for patients with high-risk blood and bon...
What is the current status of trial NCT07025538?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2026-06-01. Estimated completion is 2028-06-22.
What interventions are being tested in trial NCT07025538?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Best Practice (OTHER), Ruxolitinib (DRUG), Biomarker Analysis (OTHER).
Who is sponsoring clinical trial NCT07025538?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07025538's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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