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

Ruijin Hospital22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasal Type Extranodal NK/T-Cell Lymphoma

Interventions

PegaspargaseDRUG

Pegaspargase 3750IU administered by intramuscular injection on Day 1 of each 21-day cycle for 6 cycles in induction treatment

Anti-PD-1 monoclonal antibodyDRUG

Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 2 of each 21-day cycle for 6 cycles in induction treatment Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1 of each 21-day cycle for up to 28 cycles in maintenance treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Complete response rate

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.

Time frame: At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcomes

Overall response rate

Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.

Time frame: At the end of Cycle 6 (each cycle is 21 days)

Progression free survival

Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy, or death from any cause, whichever occurred first.

Time frame: Baseline up to data cut-off (up to approximately 4 years)

Overall survival

Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.

Time frame: Baseline up to data cut-off (up to approximately 4 years)

Duration of response

Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

Time frame: Baseline up to data cut-off (up to approximately 4 years)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.