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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Antibodies; Antibodies, Monoclonal; Asparaginase; Immunoglobulins; Pegaspargase

Criteria

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.