Actively Recruiting
A Prospective Clinical Study of Selinexor, Pegaspargase, and Dexamethasone in Treating Early Stage I/II NK/T-Cell Lymphoma
Led by Mingzhi Zhang · Updated on 2025-07-14
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
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 NK/T-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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months or until tumor volume has reduced
Participants receive an oral treatment regimen of Selinexor, Pegaspargase, and Dexamethasone for early stage I/II NK/T cell lymphoma.
Visits scheduled according to treatment protocol
Trial Site Locations
Total: 1 location
1
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
Z
Zhang Mingzhi Mingzhi Zhang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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