A Prospective Clinical Study of Selinexor+Pegaspargase+Dexamethasone in the Treatment of Stage Ⅰ/Ⅱ NK/ T-Cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);

• Pre-survival time \> 6 months;

• 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);

• Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;

• 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);

• 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;

• Renal function: serum creatinine ≤1.5×ULN;

• 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;

• The newly treated patient had not received other tumor-related treatment in the past;

⁃ Subjects voluntarily participate in the clinical trial, sign informed consent, and cooperate with follow-up;

Locations
Other Locations
China
Oncology Department of The First Affilliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Zhang Mingzhi Mingzhi Zhang, PhD
Mingzhi_zhang@163.com
86 13838565629
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mingzhi Zhang

This content was sourced from clinicaltrials.gov