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Phase 2Not yet recruitingPriority 3 · Moderate priorityNCT07554482

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

ClinicalTrials.gov

Plain-language summary

This Phase 2 trial is studying Pegaspargase (PEG) Asparaginase, Gemcitabine (GEM), and other medications for people with NK/T-cell lymphoma. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years to 75 Years years
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

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.

Drugs / treatments
Pegaspargase (PEG) Asparaginase, Gemcitabine (GEM), Oxaliplatin, Selinexor, radiotherapy
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

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

NCT07554482

Phase: Phase 2 | Status: Not yet recruiting | Priority: Medium

Plain-language summary

This Phase 2 trial is studying Pegaspargase (PEG) Asparaginase, Gemcitabine (GEM), and other medications for people with NK/T-cell lymphoma. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

Who can join

  • Age 18 Years to 75 Years years
  • Must be well enough for treatment (adequate performance status)

What's being tested

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.

Drugs / treatments: Pegaspargase (PEG) Asparaginase, Gemcitabine (GEM), Oxaliplatin, Selinexor, radiotherapy

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 34 patients

Primary endpoint: Complete response (CR) rate

Ages: 18 Years to 75 Years

Start date: 2026-05-15 | Est. completion: 2029-04-30

Locations

0 US sites · 1 total

Contact

Liang Wang, M.D. | wangliangtrhos@126.com | +861058266633

Sponsor: Beijing Tongren Hospital (OTHER)

Tags

ENKTL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07554482

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.