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

Sponsor
Mingzhi Zhang
Study ID
NCT06559553
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • NKTCL
  • Selinexor

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor+pegaspargase+dexamethasone — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 1, 2024
Status verified
Jul 2025
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

CRR [ Time Frame: From date of randomization until the date tumor volume has reduced, assessed up to 36 months ]

Central Contacts