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Nongchang","065201",{"type":42,"coordinates":211},[212,213],79.81606,33.6106,{"lat":213,"lon":212},{"type":216,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100579423","phase-4-study-of-efficacy-and-safety-of-ruxolitinib-in-chinese-participants-with-corticosteroid-refractory-chronic-graft-vs-host-disease-100579423",false,"NCT06824103","Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease","A Single-arm Multi-center Study of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft Versus Host Disease After Allogeneic Stem Cell Transplantation","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Male or female Chinese participants aged 12 or older at the time of informed consent\n* 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.\n* Evident myeloid and platelet engraftment:\n\n  * Absolute neutrophil count (ANC) \\>1,000\u002Fmm3 AND\n  * Platelet count ≥25,000\u002Fmm3\n\nNote: 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.\n\n* 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.\n\n  * Moderate cGvHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1.\n  * Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3.\n* Participants currently receiving systemic corticosteroids for the treatment of cGvHD for a duration of \\\u003C 12 months prior to Cycle 1 Day 1, and have a confirmed diagnosis of corticosteroid refractory cGvHD defined per 2014 NIH consensus criteria (Martin et al 2015) irrespective of the concomitant use of a calcineurin inhibitor, as follows:\n\n  * A lack of response or disease progression after administration of minimum prednisone 1 mg\u002Fkg\u002Fday for at least 1 week (or equivalent) OR\n  * Disease persistence without improvement despite continued treatment with prednisone at \\>0.5 mg\u002Fkg\u002Fday or 1 mg\u002Fkg\u002Fevery other day for at least 4 weeks (or equivalent) OR\n  * Increase to prednisone dose to \\>0.25 mg\u002Fkg\u002Fday after two unsuccessful attempts to taper the dose (or equivalent)\n* Participants has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n\nExclusion Criteria:\n\nFor a full list of exclusion criteria, refer to Section 5.2. Key exclusion criteria include\n\n* Participants who have received two or more systemic treatments for cGvHD in addition to corticosteroids ± CNI for cGvHD.\n* Participants who have received ROCK2 inhibitors for cGvHD.\n* Participants that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment\n\nNote: Participants receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.\n\n* Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1.\n* Failed prior alloSCT within the past 6 months from Cycle 1 Day 1.\n* Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed.\n* SR-cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.\n\nOther protocol-defined inclusion\u002Fexclusion may apply.","ALL","12 Years","100 Years",{"count":228,"type":229},50,"ESTIMATED","INTERVENTIONAL",[232],"PHASE4","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).",[235,236,237],"Graft vs. Host Disease","Chronic Graft vs. Host Disease","Corticosteroid-refractory Chronic Graft vs. Host Disease",[239,240,241,242,20,243,244,245,246],"cGvHD","GvHD","SR-cGvHD","ruxolitinib","Chinese adult","Pediatric","Corticosteroid","refractory","2026-06-04",{"date":249,"type":250},"2026-06-08","ACTUAL",{"date":252,"type":250},"2025-09-09",{"date":254,"type":229},"2031-05-23",{"name":23,"class":6},22]