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NOT YET RECRUITING
NCT07574528
PHASE2

A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma (ENKTL).

Official title: A Multicenter, Single-Arm, Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

47

Start Date

2026-05-06

Completion Date

2031-05-06

Last Updated

2026-05-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Sintilimab

Sintilimab will be given at 200 mg by intravenous infusion.

DRUG

Pegaspargase

Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.

DRUG

Selinexor

Selinexor will be given orally once weekly at 60mg.

RADIATION

radiotherapy

Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, 广东省 - Guangdong Sheng, China