An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

Key Inclusion Criteria: * Male or female, 12 years of age or older. * Have undergone an allo-HSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible. * Clinically suspected all grades chronic GVHD according to NIH Consensus Criteria that is refractory or intolerant to corticosteroids, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic regimen. Clinical suspicion of steroid-refractory chronic GVHD by the treating physician is also sufficient. * Evidence of myeloid engraftment (eg, absolute neutrophil count ≥ 1.0 × 10\^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed. * Evidence of platelet engraftment (ie, platelets ≥ 20 × 10\^9/L). * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3. * Be willing to avoid pregnancy or fathering children based on 1 of the following criteria: * Women of non-childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea). * Woman of childbearing potential who has a negative serum pregnancy test at screening and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy…