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RecruitingNCT06559553SelinexorUpdated Jul 14, 2025

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

A Phase 1/2 interventional study of Selinexor+pegaspargase+dexamethasone in NKTCL and Selinexor, sponsored by Mingzhi Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-14.

Sponsored by Mingzhi Zhang · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma

Read the detailed description

Patients with early NK/T cell lymphoma were treated with an oral regimen of \"Selinisol + pemaspartase + dexamethasone\"

02

Conditions studied

  • NKTCL
  • Selinexor

Keywords

  • NKTCL
  • Selinexor
03

In context

Lead sponsor

Mingzhi Zhang is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);
  2. Pre-survival time > 6 months;
  3. The pathological tissue was confirmed as NK/T cell lymphoma (the pathological report of the first three months of enrollment could be accepted) (Note: If there is any doubt about the pathological diagnosis, domestic third-party consultation could be organized);
  4. Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;
  5. Acceptable hematological indicators, no contraindications to chemotherapy; Neutrophil absolute value ≥1.0×10\^9 /L, platelet ≥75×10\^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
  6. Liver function: direct bilirubin ≤1.5× upper limit reference value; Glutamic pyruvic transaminase or glutamic oxalacetic transaminase ≤2.5× upper limit reference value; Alkaline phosphatase ≤3×ULN in non-bone invaded patients;
  7. Renal function: serum creatinine ≤1.5×ULN;
  8. Female and male patients of reproductive age and their spouses are willing to use adequate contraception throughout the study period, and female patients of reproductive age must have a negative serum pregnancy test within 7 days before the first dose;
  9. The newly treated patient had not received other tumor-related treatment in the past;
  10. Subjects voluntarily participate in the clinical trial, sign informed consent, and cooperate with follow-up;

Exclusion criteria

Exclusion Criteria:

  1. Refuse to collect blood samples;
  2. Previous allergy to any of the drugs in the program;
  3. Pregnant and lactating women;
  4. Major diseases that the investigator believes can cause interference with the test;
  5. Combined with other tumors;
  6. There are contraindications related to therapeutic drugs in the program;
  7. Persons with serious mental illness;
  8. Participating in other clinical trials;
  9. Previous anti-tumor therapy (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);
  10. Other serious medical conditions that may limit participants\' participation in the trial, such as uncontrolled diabetes; Severe cardiac insufficiency (NYHA grade II or above); Acute coronary syndrome within the last 6 months; Coronary revascularization such as stenting, coronary artery bypass surgery, and other heart and large vessel related procedures within the last 6 months; Severe arrhythmias include frequent ventricular early, ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure >150mmHg, diastolic blood pressure >100mmHg. Gastric ulcers (stomach ulcers that researchers have determined are at risk of perforation); Active autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren\'s syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory disease (such as obstructive pulmonary disease and a history of bronchospasm);
  11. Hemophagic cell syndrome;
  12. Researchers do not consider it suitable for inclusion;
  13. Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis test positive.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Selinexor+pegaspargase+dexamethasone

    Nuclear export protein-1 is the main transporter protein for leucine-rich proteins to enter the cytoplasm from the nucleus through the nuclear pore complex, which is overexpressed in malignant tumor cells. Studies have shown that Selinexor inhibits the nuclear export of viral mRNA such as EBV, and has good therapeutic potential for NKTCL. Selinexor combined with pemaspartase, dexamethasone and sequential radiotherapy may be the golden choice for early NK/T cell lymphoma, improving the local control rate of the disease and improving the overall prognosis of NK/T cell lymphoma.

    Drug: Selinexor+pegaspargase+dexamethasone

Interventions

  • DrugSelinexor+pegaspargase+dexamethasone

    Nuclear export protein-1 is the main transporter protein for leucine-rich proteins to enter the cytoplasm from the nucleus through the nuclear pore complex, which is overexpressed in malignant tumor cells. Studies have shown that Selinexor inhibits the nuclear export of viral mRNA such as EBV, and has good therapeutic potential for NKTCL. Selinexor combined with pemaspartase, dexamethasone and sequential radiotherapy may be the golden choice for early NK/T cell lymphoma, improving the local control rate of the disease and improving the overall prognosis of NK/T cell lymphoma.

06

What researchers measure

Primary outcomes

  1. CRR

    The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete mitigation.

    Time frame: From date of randomization until the date tumor volume has reduced, assessed up to 36 months

07

Study locations

1 of 1 sites recruiting
  • Oncology Department of The First Affilliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06559553
Lead sponsor
Mingzhi Zhang
Responsible party
Mingzhi Zhang (the director of oncology department of the first affiliated hospital, Zhengzhou University) — Sponsor-investigator
First posted
Aug 19, 2024
Start date
Sep 1, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 14, 2025

Study contacts

Zhang Mingzhi Mingzhi Zhang, PhD
Contact
Mingzhi_zhang@163.com
86 13838565629

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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