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Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation

StatusRecruiting
PhasePhase 1
Started2026-04-29
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
critical
Study Status, Contacts/Locations v7
Recruitment resumed after suspension
Recruitment suspended: Safety Issues
Study sitesdetails revised at 1 of 1 site
2026-07-10
minor
Study Status v6
Start dateestimated 2026-06-01→confirmed 2026-04-29
2026-04-16
notable
Suspended→Recruiting Study Status, Contacts/Locations v5
Primary completion moved earlier: 2029-06-22 → 2028-06-22
Completion moved earlier: 2029-06-22 → 2028-06-22
Trial statusSuspended→Recruiting
Reason stoppedbudget→not stated
Start date2026-03-09→2026-06-01
Study sitesdetails revised at 1 of 1 site
2026-02-20
minor
Study Status v4
Re-verified, no change to tracked fields
2026-01-20
notable
Recruiting→Suspended Study Status, Contacts/Locations v3
Trial statusRecruiting→Suspended
Reason stoppednot stated→budget
Primary completion date2028-04-05→2029-06-22
Completion date2028-04-05→2029-06-22
Start date2025-12-09→2026-03-09
Study sitesdetails revised at 1 of 1 site
Show 2 earlier versions
2025-12-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-11-10
minor
Study Status v1
Primary completion date2025-10-09→2028-04-05
Completion date2025-10-09→2028-04-05
Start date2025-10-09→2025-12-09
2025-06-13
minor
Original filing
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.
Trial Details
NCT Number NCT07025538
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Hematopoietic and Lymphatic System Neoplasm
Enrollment 42 participants
Start Date 2026-04-29
Primary Completion 2028-06-22 (estimated)
Study Completion 2028-06-22 (estimated)
Updated on ClinicalTrials.gov 2026-09-22