Sintilimab: Sintilimab will be given at 200 mg by intravenous infusion.
Pegaspargase: Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.
Selinexor: Selinexor will be given orally once weekly at 60mg.
radiotherapy: Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Histologically confirmed extranodal natural killer/T-cell lymphoma.
* Primary lesion located in the nasal cavity or upper aerodigestive tract.
* Stage I to II disease.
* At least one measurable or evaluable lesion according to Lugano 2014 criteria.
* Adequate organ and bone marrow function.
Exclusion Criteria:
* 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.
* Known history of human immunodeficiency virus infection or acquired immunodeficiency syndrome.
Primary outcome measure(s)
Complete Response Rate (CRR) — Up to approximately 6 months The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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