Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD

Inclusion Criteria:

- Have undergone first allo-HSCT from any donor source (matched unrelated donor,
sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood
for hematologic malignancies. Recipients of nonmyeloablative and myeloablative
transplants are eligible.

- Clinically suspected Grades IIB to IVD acute GVHD as per modified MN-CIBMTR criteria,
occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic
program.

- Subjects may, but are not required to, have previously received corticosteroids for
acute GVHD:

- Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.

Exclusion Criteria:

- Has received more than 1 hematopoietic stem cell transplantation.

- Has progressed on more than 2 prior treatment regimens for acute GVHD.

- Presence of an active uncontrolled infection.

- Subjects with relapsed primary disease, or subjects who have been treated for relapse
after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was
performed.

- Inadequate recovery from toxicity and/or complications from the prior allo-HSCT.

- Any corticosteroid therapy (for indications other than GVHD) at doses > 1 mg/kg per
day methylprednisolone or equivalent within 7 days of randomization.

- Previously received JAK inhibitor therapy for any indication.