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).

Study Overview

• Status: Not yet recruiting
• Conditions: NKTCL
• Intervention / Treatment: Drug: Sintilimab; Drug: Pegaspargase; Drug: Selinexor; Radiation: radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 47
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qingqing Cai; Phone Number: +8618353201165; Email: caiqq@sysucc.org.cn

Study Locations

• China
  • 广东省 - Guangdong Sheng
    • Guangzhou, 广东省 - Guangdong Sheng, China, 510060
      • Sun yat-sen University Cancer Center
      • Contact: Qingqing Cai; Phone Number: 18353201165; Email: baisr@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sintilimab, pegaspargase, and selinexor; Patients will receive induction therapy with sintilimab, pegaspargase, and selinexor every 21 days for up to 4 cycles, followed by radiotherapy.	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; Selinexor will be given orally once weekly at 60mg.; Radiation: radiotherapy; Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	The proportion of patients who achieve complete response or partial response, as assessed according to Lugano 2014 response criteria.	Up to approximately 6 months
Progression-Free Survival (PFS)	The time from enrollment to disease progression or death from any cause, whichever occurs first.	Up to 3 years
Overall Survival (OS)	The time from enrollment to death from any cause.	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.	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.	Up to 3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2026
• Primary Completion (Estimated): March 6, 2028
• Study Completion (Estimated): May 6, 2031

Study Registration Dates

• First Submitted: May 2, 2026
• First Submitted That Met QC Criteria: May 2, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Radiotherapy; selinexor; pegaspargase; sintilimab
• Other Study ID Numbers: B2026-235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No