Study design and patients
ALK-negative ALCL, AITL, PTCL-NOS, ALK-ALCL, NK/T-cell neoplasms or central nervous system, ENKTL
DISEASE PROGRESSION, INFILTRATION, HEMOPHAGOCYTIC SYNDROME, DISEASE, REMISSION, ONCOLOGY
This was an open-label, multicenter, phase II, single-arm study. Patients were enrolled in six centers in China between October 2018 and March 2021. Patients with PTCL-NOS, AITL, ENKTL, and ALK-negative ALCL (ALK-ALCL), as defined by the WHO (2016), were eligible. The key inclusion criteria were: ≥18 years of age, relapsed or refractory to one or more systemic therapies, had measurable disease, had an Eastern Cooperative Oncology Group performance status of 0–2, had adequate bone marrow and organ function and had a life expectancy of at least 12 weeks. Refractory disease refers to the failure to achieve complete or partial remission after the latest treatment, whereas relapsed disease refers to confirmed disease progression after the latest treatment.Patients were excluded if they had other prespecified NK/T-cell neoplasms or central nervous system infiltration. Additional exclusion criteria included a history of prior allogeneic HSCT; less than 90 days after autologous HSCT; previously used anti-PD-1, anti-PD-L1 or other ICIs; hemophagocytic syndrome at initial diagnosis (The study was approved by an independent ethics committee (2018YJZ34) and was conducted in accordance with the Declaration of Helsinki and Guidelines for Good Clinical Practice. All enrolled patients provided informed consent. This study was registered with ClinicalTrials.gov, NCT03701022.