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

Inclusion Criteria:

- Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no
circulating blasts and < 5% blasts in the bone marrow.

- Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic
leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell,
or mantle cell lymphoma must have chemosensitive disease at time of transplant.
Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant.

- Must be candidates for reduced-intensity conditioning regimens.

- Must be candidates for peripheral blood stem cell transplants.

- Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group
Performance Status score of 0 to 2.

- Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or
calculated by Cockcroft-Gault equation.

- Be willing to avoid pregnancy or fathering children.

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.