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

ConditionsNKTCLSelinexor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMingzhi Zhang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Refuse to collect blood samples;

Previous allergy to any of the drugs in the program;

Pregnant and lactating women;

Major diseases that the investigator believes can cause interference with the test;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Selinexor+pegaspargase+dexamethasoneExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mingzhi Zhang

Lead sponsor

Zhengzhou University

Sponsor institution