A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sintilimab, Pegaspargase, Selinexor, radiotherapy.
- Who it may be relevant to
- Registry conditions: NKTCL. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
Interventions
- 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.
Primary outcome measures
- Complete Response Rate (CRR) [Time frame: Up to approximately 6 months]
Secondary outcome measures (5)
- Overall Response Rate (ORR) [Time frame: Up to approximately 6 months]
- Progression-Free Survival (PFS) [Time frame: Up to 3 years]
- Overall Survival (OS) [Time frame: Up to 3 years]
- Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE) [Time frame: Up to 30 days after the last study treatment]
- Change in Quality of Life [Time frame: Up to 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07574528 · B2026-235