GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Chronic Graft-versus-host Disease
In brief
The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Key facts
- Study ID
- NCT03584516
- Run by
- Incyte Corporation
- People needed
- 155
- Starts
- 2019-01-17
- Expected to finish
- 2023-11-03
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria
- Underwent allogeneic stem cell transplantation (allo-HCT)
- Karnofsky Performance Status score ≥ 60%.
- Evidence of myeloid and platelet engraftment.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
You may not qualify if…
- Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD.
- Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP).
- Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization.
- cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence.
- Evidence of relapsed primary malignancy.
Where it is running
- University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute — Little Rock, Arkansas, United States
- City of Hope National Medical Center — Duarte, California, United States
- University of California San Diego Medical Center, Moores Cancer Center — La Jolla, California, United States
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
- Augusta University - Medical College of Georgia — Augusta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Illinois Cancer Specialists — Chicago, Illinois, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Advocate Lutheran General Hospital - Oncology Specislists Sc — Park Ridge, Illinois, United States
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- University of Kansas Hospital Authority — Westwood, Kansas, United States
- Tulane University — New Orleans, Louisiana, United States
- University of Maryland - Greenebaum Cancer Center — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Spectrum Health — Grand Rapids, Michigan, United States
- University of Minnesota, Masonic Cancer Center — Minneapolis, Minnesota, United States
- Saint Louis University Cancer Center — St Louis, Missouri, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- University of Rochester, James P. Wilmot Cancer Center — Rochester, New York, United States
- Stony Brook University Medical Center — Stony Brook, New York, United States
- University of Arizona Cancer Center - Out Pt. — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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