Duke logo

Incyte: P3 Randomized study of Ruxolitinib vs BAT in pts w/ corticosteroid -refractory GvHD - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and effectiveness of the drug ruxolitinib in patients with moderate to severe corticosteroid refractory chronic graft vs host disease.

What is the Condition Being Studied?

Chronic graft vs host disease that is refractory (does not respond) to steroids

Who Can Participate in the Study?

Patients older than 12 who have been diagnosed with moderate or severe chronic graft vs host disease and had an allogeneic stem cell transplant.

Age Group
Adults, Children

What is Involved?

If you choose to join this study, you will
- Be randomized (as in the flip of a coin) to receive
-- A study drug called I11ruxolitinib by mouth twice a day or
-- Best available therapy (selected by your physician)

- You will be treated or followed for three years
- You must be able to swallow pills

Study Details

Full Title
A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft vs host disease after allogenic stem cell transplantation (REACH 3)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00085097
NCT:NCT03112603
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698