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).
Age 18 years or older.
No prior systemic treatment for lymphoma, except short-term corticosteroids for symptom control.
Life expectancy of more than 3 months.
Eastern Cooperative Oncology Group performance status of 0 to 2.
Aggressive NK-cell leukemia.
Significant dysfunction of major organs.
Known hypersensitivity to any study drug or its components, or contraindication to any study treatment.
Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use effective contraception.
Single group
Sintilimab
DrugSintilimab will be given at 200 mg by intravenous infusion.
Pegaspargase
DrugPegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.
Selinexor
DrugSelinexor will be given orally once weekly at 60mg.
radiotherapy
RadiationPatients will receive induction treatment for up to 4 cycles, followed by radiotherapy.
Complete Response Rate (CRR)
The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria.
Overall Response Rate (ORR)
The proportion of patients who achieve complete response or partial response, as assessed according to Lugano 2014 response criteria.
Progression-Free Survival (PFS)
The time from enrollment to disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
The time from enrollment to death from any cause.
Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)
The incidence and severity of adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
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