GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

Exclusion Criteria

• •Has previously received an allogenic hematopoietic stem cell transplant.
• •Presence of an active uncontrolled infection.
• •Known HIV infection.
• •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
• •Prior malignancies.
• •Severe organ dysfunction.
• •Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
• •Currently breastfeeding.
• •Known allergies, hypersensitivity, or intolerance to any of the study medications.
• •Receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study.
• •History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to \> 28 days after transplant.
• •Post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.