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Itacitinib or Placebo with Corticosteroids in cGVHD - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug (itacitinib) will work better than the placebo when used together with corticosteroids for moderate or severe chronic GVHD.

What is the Condition Being Studied?

Graft versus- host disease (GVHD)

Who Can Participate in the Study?

Adults who:
- Have GVHD
- Have underwent allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood)

What is Involved?

If you choose to join this study, you will have:
- A screening visit
- To take the study drug, itacitinib, by mouth
- A physical exam and the doctor will go over any side effects that you may have experienced
- A review of your ability to perform daily activities
- Blood tests
- An ECG/EKG done
- An assessment of your cGVHD symptoms
- To complete Quality of Life questionnaires

Study Details

Full Title
A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft Versus Host Disease (GRAVITAS-309)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00101558
NCT:NCT03584516
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698