NCT03936452

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

Completed Phase 2 Last updated 9 June 2022

What this trial tests

Phase 2 trial testing Sintilimab in Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type in 55 participants. Completed in 30 December 2021.

Timeline

28 April 2019

Primary endpoint
30 December 2021

30 December 2021

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	28 April 2019
Primary completion	30 December 2021
Estimated completion	30 December 2021
Sites	1 location across China

Drugs / interventions tested

• Sintilimab — full drug profile →

Conditions studied

• Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type — all drugs for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type →
• Early Stage — all drugs for Early Stage →
• Anlotinib — all drugs for Anlotinib →
• Peg-aspargase — all drugs for Peg-aspargase →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type or Early Stage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The contemporary management of cancers of the sinonasal tract in adults.
   Thawani R, Kim MS, Arastu A, Feng Z, et al · · 2023 · cited 95× · PMID 35916666 · DOI 10.3322/caac.21752
2. Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4).
   Tao R, Fan L, Song Y, Hu Y, et al · · 2021 · cited 86× · PMID 34702811 · DOI 10.1038/s41392-021-00768-0
3. Extranodal Natural Killer/T-cell Lymphoma, Nasal Type: Diagnosis and Treatment.
   van Doesum JA, Niezink AGH, Huls GA, Beijert M, et al · · 2021 · cited 26× · PMID 33458595 · DOI 10.1097/hs9.0000000000000523
4. Treatment of extranodal NK/T-cell lymphoma: From past to future.
   Yan Z, Yao S, Wang Z, Zhou W, et al · · 2023 · cited 22× · PMID 36825002 · DOI 10.3389/fimmu.2023.1088685
5. Novel target and treatment agents for natural killer/T-cell lymphoma.
   Tian XP, Cao Y, Cai J, Zhang YC, et al · · 2023 · cited 19× · PMID 37480137 · DOI 10.1186/s13045-023-01483-9
6. A phase II study of sintilimab, anlotinib, and pegaspargase sandwiched with radiotherapy as first-line therapy in patients with newly diagnosed, stage I-II extranodal natural-killer/T-cell lymphoma.
   Sun P, Li Y, Li C, Ren K, et al · · 2023 · cited 14× · PMID 36970971 · DOI 10.1002/ajh.26922
7. Advances and challenges of immunotherapies in NK/T cell lymphomas.
   He L, Chen N, Dai L, Peng X. · · 2023 · cited 12× · PMID 38026157 · DOI 10.1016/j.isci.2023.108192
8. Combination of Anti-PD-1 Antibody, Anlotinib and Pegaspargase "Sandwich" With Radiotherapy in Localized Natural Killer/T Cell Lymphoma.
   Sun P, Wang Y, Yang H, Chen C, et al · · 2022 · cited 11× · PMID 35237257 · DOI 10.3389/fimmu.2022.766200