A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
NCT07574528 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2026-05-08
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).
Conditions
- NKTCL
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 will be given orally once weekly at 60mg.
- RADIATION
-
radiotherapy
Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-06
- Primary Completion
- 2028-03-06
- Completion
- 2031-05-06
Countries
- China
Study Locations
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