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

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

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).

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.