Upfront Ruxolitinib for Chronic Graft-vs-host Disease

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06695507
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Participants will receive ruxolitinib for 6 months.

Study Details

While hematopoietic stem cell transplant (HSCT) is an effective therapy, graft versus host disease (GVHD) is the most significant complication after HSCT. Corticosteroids (or steroids) have been the mainstay of treatment for chronic GVHD for many decades now. Increasingly, newer immunosuppressive and immunomodulating agents are being studied in adults and children affected by cGVHD. Ruxolitinib is one of these promising newer agents, which has been shown to be effective in the treatment of cGVHD in both children and adults. Currently, ruxolitinib is generally added to a patient's treatment regimen after (or with) a course of high dose steroids. The purpose of this study is to examine the effectiveness of upfront single agent ruxolitinib for cGVHD.

Key Dates

Start date
Feb 19, 2025
Status verified
Feb 2026
Primary completion
Aug 20, 2025
Completion
Sep 18, 2025

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib Treatment

Primary Outcome Measure

Overall Response Rate [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

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