GRAVITAS-309: Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Trial Status: Active
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).
- Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria
- Underwent allogeneic stem cell transplantation (allo-HCT) from any donor human leukocyte antigen (HLA) type (matched-related, matched-unrelated, or mismatched related or unrelated donor) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative or reduced intensity conditioning are eligible.
- Karnofsky Performance Status score ≥ 60%.
- Evidence of myeloid and platelet engraftment (ie, absolute neutrophil count ≥ 1.0 × 10^9/L and platelet count ≥ 25 × 10^9/L).
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
- 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 and concomitant use of calcineurin inhibitors as well as topical/inhaled steroids is acceptable.
- 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. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
- Evidence of relapsed primary malignancy or receipt of treatment for relapse after the allo-HCT was performed.
- Corticosteroid therapy at doses > 0.25 mg/kg per day methylprednisolone or equivalent within 7 days of randomization.
Banner University Medical Center - Tucson
City of Hope Comprehensive Cancer Center
University of California San Diego
University of Miami Miller School of Medicine-Sylvester Cancer Center
Indiana University / Melvin and Bren Simon Cancer Center
Contact: Jack Erie Wilson
University of Kansas Cancer Center
Contact: Marc Morrison
University of Maryland / Greenebaum Cancer Center
Contact: Sherri Bauman
Massachusetts General Hospital Cancer Center
University of Minnesota / Masonic Cancer Center
Duke University Medical Center
Case Comprehensive Cancer Center
Thomas Jefferson University Hospital
University of Pittsburgh Cancer Institute (UPCI)
Vanderbilt University / Ingram Cancer Center
Fred Hutch / University of Washington Cancer Consortium
Trial Phase Phase III
Trial Type Treatment
- Primary ID INCB 39110-309
- Secondary IDs NCI-2019-01596
- Clinicaltrials.gov ID NCT03584516