Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma

Study Overview
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Brief Summary
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For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody.

Detailed Description
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For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. The investigators previously reported one-year progression free survival rate of 22.2% for patients with positive plasma EBV-DNA at the end of treatments. Recently, anti-PD-1 antibody has been shown to be highly effective in the treatment of NK/T-cell lymphoma. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody for patients with positive plasma EBV-DNA at the end of treatments.

Official Title
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Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma: a Single Arm, Single Center, Open Label, Phase 2 Trial

Conditions
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Extranodal NK/T-cell Lymphoma, Nasal Type

Intervention / Treatment
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* Drug: toripalimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathology confirmed diagnosis of NK/T-cell lymphoma. Plasma EBV-DNA was positive at the end of first-line pegaspargase-based regimens. ECOG score of 0-3 points. The lab tests within 1 week before enrollment meets the following: Blood routine: Hb≥80g/L, PLT≥50×10e9/L. Liver function: ALT, AST, TBIL≤2 times the upper limit of normal. Renal function: Cr is normal. Coagulation: plasma fibrinogen≥1.0g/L. Cardiac function: LVEF≥50%, ECG is normal Sign the informed consent form. Voluntary compliance with research protocols. Exclusion Criteria: Patients had relapsed NK/T-cell lymphoma. Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Serious complications such as fulminant DIC. Significant organ dysfunction: respiratory failure NYHA classification≥2 chronic congestive heart failure decompensation Hepatic or renal insufficiency high blood pressure and diabetes that cannot be controlled cerebral vascular events within the past 6 months. Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require treatments within 6 months. Other experimental drugs are being used.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: For patients with positive plasma EBV-DNA at the end of treatments, anti-PD-1 antibody (toripalimab 240mg, every 3 weeks for up to one year)is given as maintenance therapy for 1 year.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression. | Drug: toripalimab<br>* 240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first<br>* Other names: anti-PD-1-antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-year progression free survival rate | progression free survival is caculated from date of study enrollment to documented disease progression or death of any reason, whichever came first | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-year overall survival rate | overall survival is caculated from date of study enrollment to documented death of any reason or last follow up, whichever came first | From date of enrollment until the date of documented death from any cause or last follow up, whichever came first, assessed up to 12 months | 
| negative conversion rate of plasma EBV-DNA | plasma EBV-DNA status converted from positive to negative | up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extranodal NK/T-cell lymphoma, PD-1 blockade, maintenance therapy