NCT03936452

Combined Treatment of Sintilimab, Peg-aspargase Plus Anlotinib in NK/T Cell Lymphoma

An Open, Single-center, Phase II Study of Sintilimab, Peg-aspargase Plus Anlotinib "Sandwich"With Radiotherapy in Previously Untreated Stage I-II Extranodal NK/T Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the treatment of previously untreated stage I-II Extranodal NK/T Cell Lymphoma with sintilimab, peg-aspargase and anlotinib, "sandwich" with radiotherapy. The primary endpoint is the complete response rate (CRR) at the end of the treatment, and the second endpoints are CRR after two cycles of the combined regimen (CRR2), overall response rate (ORR) at the end of the treatment, survival time (OS and PFS) and toxicities.

Conditions

• Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
• Early Stage
• Anlotinib
• Peg-aspargase
• Sintilimab
• Phase Two
• Open
• Radiotherapy

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy

Timeline

• Start date: 2019-04-28
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2019-05-03
• Last updated: 2022-06-09

Locations

1 site across 1 country: China