A Pilot Study of Ruxolitinib Cream to Treat Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease

Full Title

A Pilot Prospective, Randomized, Double-Blinded, Vehicle- and Comparator-Controlled Trial on Safety and Efficacy of a Topical Inhibitor of Janus Kinase 1/2 (Ruxolitinib INCB018424 Phosphate 1.5% Cream) for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease

Purpose

Graft-versus-host disease (GVHD) is a potential complication that can occur when someone receives stem cells from a donor. It happens when white blood cells called T cells from the donor attack the tissues of the patient. Chronic GVHD develops slowly and usually occurs several months after the transplant. It can affect the skin, causing non-sclerotic chronic cutaneous GVHD.

In this study, researchers are comparing the safety and effectiveness of ruxolitinib 1.5% cream with a standard moisturizer in people with non-sclerotic chronic cutaneous GVHD. Participants will receive tubes of ruxolitinib cream and a standard moisturizer; one cream will be applied to one side of the body, and the other will be applied to the other side. Ruxolitinib inhibits a protein called JAK 1/2, which is involved GVHD inflammation.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have non-sclerotic chronic cutaneous GVHD following a donated (allogeneic) stem cell transplant.
  • Patients must be able to communicate in English since they will need to report their symptoms.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alina Markova at 646-888-6010.

Protocol

18-412

Phase

II

Investigator