Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
Trial Parameters
Brief Summary
The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).
Eligibility Criteria
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female Chinese participants aged 12 or older at the time of informed consent * Able to swallow tablets.- Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible. * Evident myeloid and platelet engraftment: * Absolute neutrophil count (ANC) \>1,000/mm3 AND * Platelet count ≥25,000/mm3 Note: Use of growth factor supplementation and transfusion support is allowed during the trial, however, transfusion to reach a minimum platelet count for inclusion is not allowed during screening and at baseline. * Participants with clinically diagnosed cGvHD staging of moderate to severe according to NIH Consensus Criteria (Jagasia et al 2015) prior to Cycle 1 Day 1. * Moderate cGvHD: at least one or