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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).

Inclusion Criteria

  • 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.

Exclusion 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.

Arizona

Tucson
Banner University Medical Center - Tucson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
San Diego
University of California San Diego
Status: ACTIVE

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Jack Erie Wilson
Phone: 317-278-7866

Kansas

Kansas City
University of Kansas Cancer Center
Status: IN_REVIEW
Contact: Marc Morrison
Phone: 913-588-7585

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Sherri Bauman
Phone: 410-328-1561

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: APPROVED

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: APPROVED

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: APPROVED

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Incyte Corporation

  • Primary ID INCB 39110-309
  • Secondary IDs NCI-2019-01596
  • Clinicaltrials.gov ID NCT03584516