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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Nasal Type Extranodal NK/T-Cell Lymphoma

Treatments: Drug: Anti-PD-1 monoclonal antibody; Drug: Pegaspargase

Study type: Interventional

Funder types: Other

Identifiers

NCT04096690

RJ-NK-2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Anti-PD-1 antibody plus pegaspargase

Experimental group

Description:

Participants will receive induction treatment for six cycles of Anti-PD-1 antibody plus pegaspargase (21-day cycle) and Anti-PD-1 antibody monotherapy maintenance treatment for about 2 years (21-cycle)

Treatment:

Drug: Pegaspargase

Drug: Anti-PD-1 monoclonal antibody