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Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL

Safety and Efficacy Clinical Trial

Official title:
Safety and Efficacy of Sintilimab(S) in Combination With Histone Deacetylase Inhibitor (Chidamide, C) in Refractory and Relapsed Extranodal Natural Killer Cell/T-cell Lymphoma(EN): A Single-arm, Multicenter Phase I b/II Study(SCENT)

Clinical Trial Summary

Extranodal natural killer/T cell lymphoma(ENKTCL) is a distinct lymphoid neoplasm with aggressive course and poor outcomes. Optimal treatment strategies for advanced ENKTCL have not been fully defined.Patients with disseminated or relapsed disease have a very poor outcome,and there is no standard management for relapsed or refractory disease.Combination chemotherapy remains the mainstay of treatment.In small retrospective studies have observed very good response and survival rates in patients treated with L-asparaginase.In several prospective study that examined relapsed/refractory patients treated with SMILE outside a trial setting,the efficacy sounds good. But treatment related mortality was 7%. The regimen has toxicity, with careful attention to adverse effects and skill acquired through experience. Chidamide, a oral subtype-selective histone deacetylase inhibitor monotherapy was effective on the patients with relapsed or refractory ENKTCL in our study. Objective response rate was 50.0% (6/12) with complete response(CR) rate 33.3 %( 4/12).All four CR patients were still in disease-free more than 6.9 months (6.9-10.5). ENKTCL are invariably infected by Epstein-Barr virus(EBV).EBV-infected lymphoma cells upregulate programmed death ligand 1 (PDL1), ligand of the inhibitory receptor programmed death 1(PD1) on T cells.Ligation of PDL1 on lymphoma cells with PD1 on effector T cells suppresses T-cell cytotoxicity. The PDL1/PD1 axis is therefore a potential mechanism for ENKTCL to avert effector T-cell targeting.PD1 blockadewith pembrolizumab was a potent strategy for ENKTCL failing L-asparaginase regimens in several reports.We carried out a single, open-label, multicenter clinical trial enrolled patients with relapsed or refractory ENKTCL to safety and efficacy of sintilimab in combination With chidamide.

Clinical Trial Description

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Study Design

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Clinical Trial Details
NCT number NCT03820596
Study type Interventional
Source Sun Yat-sen University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 29, 2019
Completion date November 30, 2021
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