Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade pembrolizumab for patients with relapsed or refractory Natural Killer(NK)/T Cell Lymphoma.

Detailed Description
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Patients with relapsed or refractory NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy. The investigators have been proceeding this trial to evaluate the efficacy and safety of the immune checkpoint inhibitor PD-1 blockade, pembrolizumab in the patients with relapsed or refractory NK/T cell lymphoma.

Official Title
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PD-1 Blockade With Pembrolizumab in Relapsed or Refractory Natural Killer/T Cell Lymphoma

Conditions
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Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Intervention / Treatment
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* Drug: Pembrolizumab (PD-1 Blocking Antibody)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed evidence of relapsed or refractory NK/T cell lymphoma Before enrollment, representative formalin-fixed paraffin-embedded tumor samples (or 15 tissue sections at least) and related pathological reports are needed Previous treatment with at least one chemotherapy regimen At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments. volunteers who signed informed consent. No anti-PD1 antibody contraindication (All of the following tests are required to be finished within 14 days prior to the first research): 2.5×109/L<WBC<15×109/L, hemoglobin ≥ 90 g/L, neutrophil≥ 1.5×109/L, lymphocyte≥0.5×109/L, platelet ≥ 100×109/L, serum albumin≥2.5g/dL, ALT and AST ≤ 2×ULN, serum bilirubin≤ 1.5×ULN, serum creatine ≤ 1.5×ULN, Serum Albumin ≥ 30g/L, serum plasminogen is normal, creatinine clearance rate≥30 mL/min, INR≤1.5×ULN, APTT≤1.5×ULN Exclusion Criteria: Disagreement on blood sample collection Patients allergic of chimeric or humanized antibody Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system The evidence of CNS metastasis History of peripheral nervous disorder or dysphrenia History of active autoimmune disease and a concomitant second cancer patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigator

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-1 Blocking Antibody<br>Pembrolizumab | Drug: Pembrolizumab (PD-1 Blocking Antibody)<br>* pembrolizumab 2mg/kg, ivgtt (intravenously guttae), d1. Every three weeks for one cycle and two cycles are required at least. Efficacy and safety were evaluated every two cycles.<br>* Other names: Pembrolizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | 21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles. | every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival | up to end of follow-up-phase (approximately 24 months) | 
| Overall survival | Overall survival | up to the date of death (approximately 3 years) | 
| Median survival time | Median survival time | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK/T cell lymphoma, immunotherapy, clinical trial, RR, PFS, OS