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NCT07801248
Topical Ruxolitinib in Acute Skin GVHD (Graft Versus Host Disease)
Conditions: Acute Skin Graft Versus Host Disease (GVHD)
Sex: All
Ages: 2 Years – 35 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 10
Sponsor: Children's Hospital Medical Center, Cincinnati
Location: Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Summary
The purpose of this study is to see if ruxolitinib, a Janus Kinase (JAK) 1/2 inhibitor, is safe for people who have acute skin graft versus host disease (GVHD) following allogenic hematopoietic stem cell transplantation (HSCT).
Eligibility Criteria
Inclusion Criteria:
* Age ≥2 through age 35 years
* Acute skin GVHD (any grade).
* Underlying diagnosis of malignancy.
* No concurrent systemic immune suppression to treat acute GVHD. This excludes agents like calcineurin inhibitors, mycophenolate mofetil, and abatacept which prevent acute GVHD and are not used for treatment as per clinical practice may continue.
* Use of prior topical steroids or topical tacrolimus will be allowed but these will need to be discontinued 24 hours prior to study enrollment.
Exclusion Criteria:
* Active uncontrolled skin infections.
* History of allergic reactions to topical ruxolitinib.
* Concomitant steroids or have received investigational therapies within the previous 30 days.
Source: ClinicalTrials.gov (NCT07801248). StuddyBuddy aggregates publicly available trial information.
