Anti-PD-1 Antibody Combined With Pegaspargase in the Treatment of Advanced Stage NK/T-cell Lymphoma

The Efficacy and Safety of Anti-PD-1 Antibody in Combination With Pegaspargase in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

This open-label, single arm study will evaluate the efficacy and safety of anti-PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.

Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. L-asparaginase-based chemotherapy has improved the survival for these patients with advanced stage. However, there is no standard of care for those patients with advanced stage. Anti-PD-1 antibody has been proven its efficacy in relapsed or refractory NK/T cell lymphoma. This open-label, single arm study will evaluate the efficacy and safety of PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.

Inclusion Criteria:

• Pathologically confirmed NK/T cell lymphoma based on 2016 WHO classification
• Treatment naive
• Age > 18 years
• Advanced stage
• Must has measurable lesion in CT or PET-CT prior to treatment
• ECOG 0,1,2
• Informed consented

Exclusion Criteria:

• Aggressive NK/T-cell leukemia
• Has accepted PD-1,PD-L1 or PD-L2 antibody before
• Has accepted autologous Stem cell transplantation before
• History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
• Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
• Primary CNS lymphoma
• Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<50*10^9/L; ALT or AST >3*ULN; Creatinine>2*ULN
• Other uncontrollable medical condition that may that may interfere the participation of the study
• Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
• HIV infection
• HBV-DNA or HCV-RNA positive
• Diagnosed immunodeficiency or received systemic corticoid therapy 2 weeks prior to first dose.
• Received attenuated live vaccine 4 weeks prior to first dose.