Study of Glasdegib for Sclerotic Chronic Graft-vs-Host Disease - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if an experimental study drug called glasdegib (Daurismo) is helpful in managing the skin thickening seen in people that have chronic GVHD.

What is the Condition Being Studied?

Skin Thickening and/or Joint Tightening Caused by Chronic Graft-vs-Host Disease (GVHD)

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with moderate or severe skin thickening and/or joint tightening caused by chronic GVHD
- Have been previously treated for skin thickening and/or joint tightening caused by chronic GVHD
- Have not been hospitalized with an infection in the last 8 weeks
- Do not have uncontrolled heart disease or require oxygen
- Do not have active cancer at the time of study enrollment

For more information about who can join this study, please contact the study team at surya.nagesh@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join the study, you will:
- Take the study drug by mouth every day for up to 24 months (2 years)
- Visit our clinic up to 18 times over 24 months
- Answer questionnaires
- Have physical exams
- Have blood draws
- Have heart scans (ECG)
- Have breathing tests

We will ask you for a skin biopsy before you start taking the study drug, and we will ask you for another one after you've been taking the study drug for 6 months. These procedures are optional.

Study Details

Full Title
A Single-Arm, Open-Label, Phase I/II Study of Glasdegib for Sclerotic Chronic Graft-vs-Host Disease
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00104619
NCT: NCT04111497
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698