Topical Ruxolitinib for Cutaneous Chronic Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

Overseen byAlina Markova, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.

Eligibility Criteria

Adults and minors (12+) who have had a stem cell transplant and are now dealing with non-sclerotic chronic skin GVHD can join. They must not be using other skin treatments, their systemic therapy should be stable for 4 weeks, and they need to apply the cream themselves or get help doing so.

Inclusion Criteria

I have a skin condition from a transplant affecting at least 2% of my body.

I have had a stem cell transplant from a donor.

I will stop all skin treatments, including creams and light therapy, on the first day of the study.

See 4 more

Exclusion Criteria

I have a severe skin condition from a stem cell transplant.

I am using or plan to use skin treatments like creams, light therapy, or laser therapy.

I am changing my medication to treat skin GVHD during the study.

See 1 more

Treatment Details

Interventions

Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe trial is testing Ruxolitinib cream against standard moisturizers to see which is better for treating chronic skin issues caused by graft-versus-host disease after a stem cell transplant.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: topical ruxolitinib BID to right side of face/bodyExperimental Treatment2 Interventions

And topical moisturizer BID to left side of face/body.

Group II: topical ruxolitinib BID to left side of face/bodyExperimental Treatment2 Interventions

And topical moisturizer BID to right side of face/body.

Ruxolitinib Cream is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Opzelura for: