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

Sponsor
Beijing Tongren Hospital
Study ID
NCT07554482
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extranodal NK/T-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pegaspargase (PEG) Asparaginase — DRUG
    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) — DRUG
    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 — DRUG
    Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle for a total of 4 cycles.
  • Selinexor — DRUG
    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 — RADIATION
    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 Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment arm
    Patients will first receive 4 cycles of P-GEMOX induction chemotherapy. 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. Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle. Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle. A total of 4 cycles will be completed. Following 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 ex

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: From the day of initiation of treatment to 8 weeks after completion of radiotherapy. ]

Central Contacts