BACKGROUND: @entity66595 is a novel @entity5759 type of subtype-selective histone deacetylase (HDAC) inhibitor with unique mechanisms of action compared with marketed HDAC inhibitors. This phase II study was to evaluate the efficacy and safety of @entity66595 in relapsed or refractory @entity3191 ( @entity3191 ) in Chinese population. @entity1 AND METHODS: @entity1 with relapsed or refractory @entity3191 of different subtypes received @entity66595 of 30 mg orally twice per week. The primary end point was overall response rate (ORR). Responding @entity1 should be confirmed at least 4 weeks after the criteria of the response were first met, and were reviewed by an independent review committee. RESULTS: Eighty-three @entity1 were enrolled and 79 @entity1 with eligible @entity3191 histology were for efficacy assessments. @entity1 enrolled over 10% were with subtypes of @entity3191 not otherwise specified (34%), @entity2108 (22%), extranodal natural killer (NK)/ @entity784 , nasal type (20%), or @entity784 ( @entity784 , 13%). The ORR was 28% (22 of 79) including 14% (11 of 79) with complete response/unconfirmed complete response (CR/CRu). Median progression-free survival and overall survival were 2.1 and 21.4 months, respectively. @entity784 @entity1 tended to have higher ORR (50%) and CR/CRu rate (40%), as well as more durable responses, to @entity66595 treatment. Most adverse events (AEs) were grade 1 or 2, and AEs >= grade 3 that occurred in >= 10% @entity1 were @entity882 (22%), @entity1210 (13%) and @entity1398 (11%), respectively. CONCLUSION: @entity66595 represents a novel oral @entity5759 class of HDAC inhibitor with significant single-agent activity and manageable @entity137 in relapsed or refractory @entity3191 , and provides a much needed treatment option in this indication in China. Results led to China Food and Drug Administration approval of @entity66595 in this indication.

Results from a multicenter, open-label, pivotal phase II study of @entity66595 in relapsed or refractory XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'PATIENTS'] @entity66595 :: ('MESH:C547816', 'Chemical') :: ['chidamide', 'Chidamide'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity3191 :: ('MESH:D016411', 'Disease') :: ['PTCL', 'peripheral T-cell lymphoma'] @entity784 :: ('MESH:D016399', 'Disease') :: ['angioimmunoblastic T-cell lymphoma', 'T-cell lymphoma', 'AITL'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity5759 :: ('MESH:C037689', 'Chemical') :: ['benzamide'] @entity2108 :: ('MESH:D017728', 'Disease') :: ['anaplastic large-cell lymphoma'] @entity1210 :: ('MESH:C536227', 'Disease') :: ['leucopenia']
@entity3191 :: (MESH:D016411,Disease) :: ['peripheral T-cell lymphoma']
