Clinical Trials

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
• 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
• 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
• Has relapsed primary disease, or has 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