Selinexor Combined With Reduced-Dose Radiotherapy For Early-Stage Extranodal NK/T-Cell Lymphoma

NCT07554482 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tongren Hospital

Phase

Phase 2

Started

2026-05-15

Last updated

2026-04-28

Condition(s) studied

Extranodal NK/T-cell Lymphoma

Investigational drug(s) / intervention(s)

Pegaspargase (PEG) Asparaginase →Gemcitabine (GEM) →Oxaliplatin →Selinexor →radiotherapy

Pegaspargase (PEG) Asparaginase: Pegaspargase at a dose of 2500 IU/m² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle for a total of 4 cycles.

Gemcitabine (GEM): Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle for a total of 4 cycles.

Oxaliplatin: Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle for a total of 4 cycles.

Selinexor: Following induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Selinexor 40 mg will be administered orally twice weekly (Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Selinexor will be given concurrently with radiotherapy for a total of 8 doses.

radiotherapy: ollowing induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Radiotherapy will be delivered at a total dose of 40 Gy in 20 fractions (2 Gy per fraction), once daily, 5 fractions per week, over 4 weeks. Radiation therapy will be performed using intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). The target volume includes the gross tumor volume (GTV) of the primary lesion before chemotherapy, with a clinical target volume (CTV) margin expansion of 1-2 cm.

Study summary

Extranodal NK/T-cell lymphoma (ENKTCL) is an Epstein-Barr virus-associated non-Hodgkin lymphoma with high incidence in Asia and Latin America. Approximately 70% of patients present with early-stage (I-II) disease confined to the upper aerodigestive tract. Radiotherapy at 50-56 Gy is the standard curative treatment, but high-dose radiotherapy causes severe toxicities including oral mucositis and xerostomia, while radiotherapy alone yields high systemic recurrence rates. Previous studies have confirmed the efficacy of P-GEMOX induction chemotherapy, verified the feasibility of reduced-dose radiotherapy in patients achieving complete response after chemotherapy, and demonstrated the radiosensitizing effect of selinexor via inhibiting IRF3-BARD1-BRCA1-mediated DNA damage repair. Moreover, international evidence supports the efficacy of 40 Gy radiotherapy combined with chemotherapy. Accordingly, this study hypothesizes that selinexor combined with 40 Gy reduced-dose radiotherapy following P-GEMOX induction chemotherapy can achieve equivalent efficacy to standard-dose radiotherapy, while markedly decreasing radiotherapy-related toxicities. This trial innovatively applies selinexor as a radiosensitizer in ENKTCL, fulfills the unmet clinical demand for efficacy-preserving toxicity reduction, and is well supported by preliminary data.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Aged 18 to 75 years, regardless of gender. * Pathologically confirmed extranodal NK/T-cell lymphoma (ENKTCL). * Ann Arbor stage I-II disease with primary lesion located in the nasal cavity or upper aerodigestive tract (UADT). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Treatment-naïve patients with no prior radiotherapy, chemotherapy or targeted therapy. * Adequate major organ function as follows: * Hematopoietic function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥100×10⁹/L, hemoglobin (Hb) ≥90 g/L. * Hepatic function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine transaminase (ALT) / aspartate transaminase (AST) ≤2.5×ULN. * Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60 mL/min. * Cardiac function: left ventricular ejection fraction (LVEF) ≥50%. * Expected overall survival ≥6 months. * Voluntarily sign the written informed consent form. Exclusion Criteria: * Non-nasal type ENKTCL, or primary lesions outside the upper aerodigestive tract (UADT), including skin, gastrointestinal tract, lung and other sites. * Patients with Ann Arbor stage III-IV disease. * Central nervous system involvement. * History of prior malignant tumors, excluding non-melanoma skin cancer or cervical carcinoma in situ cured for more than 5 years. * Active infections, including active hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infection. * Severe complications, such as uncontrolled diabetes mellitus and severe cardiopulmonary diseases. * Pregnant or lactating women. * Hypersensitivity or contraindication to any investigational drugs in this study. * Concurrent participation in other interventional clinical trials.

Primary outcome measure(s)

Complete response (CR) rate — From the day of initiation of treatment to 8 weeks after completion of radiotherapy.
CR was defined as complete response evaluated using MRI scan and PET-CT scan according to Lugano criteria.

Trial sites (1)

Facility	City	Region	Status
Beijing Tongren Hospital, Capital Medical University	Beijing	China

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Other trials for the same condition

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Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma Recruiting

Clinical and Biological Cohort Study of EBV-Positive T/NK-Cell Lymphoproliferative Diseases Recruiting

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Official registry record

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.

View NCT07554482 on ClinicalTrials.gov ↗ ← All trials in China