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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Sintilimab will be given at 200 mg by intravenous infusion.
Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.
Selinexor will be given orally once weekly at 60mg.
Sun Yat-sen University Cancer Center
Guangzhou, 广东省 - Guangdong Sheng, China
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.
Time frame: Up to approximately 6 months
Overall Response Rate (ORR)
The proportion of patients who achieve complete response or partial response, as assessed according to Lugano 2014 response criteria.
Time frame: Up to approximately 6 months
Progression-Free Survival (PFS)
The time from enrollment to disease progression or death from any cause, whichever occurs first.
Time frame: Up to 3 years
Overall Survival (OS)
The time from enrollment to death from any cause.
Time frame: Up to 3 years
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.
Time frame: Up to 30 days after the last study treatment
Change in Quality of Life
Quality of life will be assessed using the EORTC QLQ-C30 or FACT-G questionnaire.
Time frame: Up to 3 years
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Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.