What is Selinexor studying for NK/T-cell lymphoma?

Selinexor is being studied in combination with Pegaspargase and Dexamethasone to evaluate its safety and effectiveness for early-stage NK/T-cell lymphoma. The study aims to improve disease control and outcomes by targeting tumor cells and viral mRNA involved in this lymphoma type. The trial is led by Mingzhi Zhang and explores this new treatment approach.

Who may be eligible for this NK/T-cell lymphoma clinical trial?

Adults aged 18 to 70 years with confirmed early-stage NK/T-cell lymphoma may be eligible. Participants must have good organ function, no prior tumor treatment, and be willing to use contraception if of reproductive age. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this NK/T-cell lymphoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost to participants. However, personal travel expenses and other related costs may vary and are not guaranteed to be covered by the study. Participants should plan accordingly.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 70Years

All Genders

ID06559553

Study of Selinexor, Pegaspargase, and Dexamethasone for Treating Early Stage III NKT-Cell Lymphoma

Led by Mingzhi Zhang · Updated on 2025-07-14

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness and safety of a combination treatment using Selinexor, Pegaspargase, and Dexamethasone for patients with early-stage NKT-cell lymphoma. The study is designed as a Phase 1 and Phase 2 clinical trial and focuses on improving local disease control and overall prognosis in this specific type of lymphoma. Patients receive an oral regimen combining Selinexor, Pegaspargase, and Dexamethasone. Selinexor works by inhibiting nuclear export proteins that are overexpressed in malignant tumor cells, including viral mRNA such as EBV. This treatment is combined with sequential radiotherapy to potentially enhance outcomes. The study monitors the responses to this combined therapy in early-stage lymphoma. Participants will be involved in regular assessments to track tumor response and overall health. The primary outcome measured is the complete response rate CRR based on tumor volume reduction, evaluated up to 36 months from randomization. Safety and treatment effects will be closely monitored during the trial period, which runs from September 2024 through December 2026.

CONDITIONS

Brief Title

"Selinexor+Pegaspargase+Dexamethasone"in Ⅰ/Ⅱ NKTCL

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 18 and 70 years old with an ECOG performance status of 0 to 2
Expected survival time greater than 6 months
Pathological confirmation of NK/T cell lymphoma within 3 months prior to enrollment
Clinical stage I to II with at least one measurable lesion
Acceptable blood counts: neutrophils ≥1.0×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥80 g/L (except lymphoma with bone marrow infiltration)
Liver function within specified limits: direct bilirubin ≤1.5× upper limit, liver enzymes ≤2.5× upper limit, alkaline phosphatase ≤3× upper limit for non-bone invasion
Renal function with serum creatinine ≤1.5× upper limit
Willingness to use contraception during the study for patients of reproductive age; negative pregnancy test within 7 days before first dose for females
No prior tumor-related treatments
Voluntary participation with signed informed consent and agreement to follow-up

You will not qualify if you...

Refusal to provide blood samples
Allergy to any study drugs
Pregnancy or breastfeeding
Major diseases that may interfere with the study
Presence of other tumors
Contraindications to study drugs
Serious mental illness
Participation in other clinical trials
Previous anti-tumor therapies such as radiotherapy, chemotherapy, hormone therapy, biotherapy, or immunotherapy
Serious medical conditions limiting participation, including uncontrolled diabetes, severe heart failure or recent heart procedures, severe arrhythmias, uncontrolled hypertension, gastric ulcers at risk of perforation, active autoimmune diseases, severe respiratory diseases
Hemophagic cell syndrome
Investigator judgment deeming unsuitability
Positive hepatitis B core antibody with abnormal HBV DNA, positive hepatitis C antibody and RNA, positive HIV antibody, or positive syphilis test

Research Team

Zhang Mingzhi Mingzhi Zhang, PhD

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