Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/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 Sintilimab in combination with decitabine in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

Detailed Description
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Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). However, the CR rate of PD-1 antibody monotherapy is too low. Previous studies have demonstrated that decitabine may activate the T cells and enhance the efficacy of PD-1 antibodies in Hodgkin Lymphoma. Thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of NK/T cell lymphoma.

Official Title
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Combination of Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study

Conditions
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Extranodal NK/T-cell Lymphoma

Intervention / Treatment
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* Drug: Sintilimab
* Drug: Decitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria. refractory or relapsed after initial remission, or stage III-IV de novo patients PET/CT or CT/MRI with at least one objectively evaluable lesion. General status ECOG score 0-3 points. The laboratory test within 1 week before enrollment meets the following conditions: 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. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking. Sign the informed consent form Exclusion Criteria: Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded. Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months. Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy 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: treatment with sintilimab and decitabine.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>Sintilimab,200mg,ivdrip,day1 Decitabine 10mg d1-5, ivdrip, repeated every 3 weeks. | Drug: Sintilimab<br>* 200mg d1,ivdrip, repeated every 3 weeks<br>* Other names: anti-PD-1-antibody;Drug: Decitabine<br>* 10mg d1-5, ivdrip,repeated every 3 weeks<br>* Other names: hypomethylating agents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate | evaluated by PET-CT and MRI, according to Lugano 2014 criteria | 24 weeks ±7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | evaluated by PET-CT and MRI, according to Lugano 2014 criteria | 24 weeks ±7 days | 
| 1-year progression free survival rate | time from date of enrollment to date of disease progression, death of any reason, whichever comes first | up to 1year after enrollment | 
| 1-year overall survival rate | time from date of enrollment to date death of any reason | up to 1year after enrollment | 

 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, decitabine, sintilimab, hypomethylation, epigenetics