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Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL — SPENT  

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

Official title:
Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy As First-Line Treatment in Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)

Clinical Trial Summary

Aim of the trial is to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles followed by standard radiotherapy with or without concurrent sintilimab and pegaspargase administered every 3 weeks. After radiotherapy, patients with complete remission with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Clinical Trial Description

This is a multicentre, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be firstly treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles. If the patient achieves complete remission（CR）, standard radiotherapy will be performed, otherwise, they will receive concurrent chemoradiotherapy（CCRT）(radiation 50 Gy and two cycles of sintilimab and pegaspargase every 3 weeks). After radiotherapy or CCRT, patients achieving CR with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04676789
Study type Interventional
Source Sun Yat-sen University
Contact Hua Wang, MD.
Phone 0086-20-87342462
Email wanghua@sysucc.org.cn
Status Not yet recruiting
Phase Phase 2
Start date September 1, 2021
Completion date December 31, 2024
View Details
See also
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Active, not recruiting NCT03363555 - SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma Phase 2
Recruiting NCT04405375 - GPED Regimen for Relapsed/Refractory or Advanced ENKTCL Phase 2
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Active, not recruiting NCT04414163 - A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type Phase 2
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