Treatment of advanced NK/T-cell lymphoma with selinexor and chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of the XPO1 inhibitor selinexor combined with the XCOPL chemotherapy regimen in patients with newly diagnosed, pathologically confirmed advanced NK/T-cell lymphoma. Participants will undergo treatment cycles lasting three weeks each, with a total of 6-8 cycles planned. Safety assessments and PET-CT evaluations will be conducted to monitor treatment response, and those achieving partial remission may switch to a second-line regimen. The study aims to improve outcomes for patients with this aggressive form of lymphoma.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age≥14 years, male or female;
* Pathologically confirmed newly diagnosed NK/T cell lymphoma according to WHO classification criteria 2016;
* At least one measurable lesion, defined as bidimensionally measurable, intranodal lesion \> 1.5 cm in short axis and extranodal lesion \> 1.0 cm in short axis;
* ECOG score 0\~2;
* Clinical stage III\~IV;
* Normal major organ function, meeting the following definitions: Hematology: WBC ≥ 3.5 x 10 9/L, PLT ≥ 75 x 10 9/L, Hb ≥ 80 g/L; Liver and kidney function: AST and ALT ≤ 3.0 ULN; TBIL ≤ 2.0 mg/dL; CCr ≥ 60 mL/min; liver and kidney function impairment caused by tumor compression is not limited by this; Fibrinogen: normal at first cycle
* Expected survival \> 6 months
* Agree to use effective contraception;
* Understand and voluntarily sign written informed consent

Exclusion Criteria:

* Prior allogeneic HCT (allo-HCT)
* Active autoimmune disease
* Primary central nervous system lymphoma;
* Patients with infection which requiring treatment. Could be re-enrollment after infection control;
* Known history of human immunodeficiency virus (HIV) infection
* Known hypersensitivity to the study drug or any of its excipients;
* Presence of other active malignancy requiring treatment that could interfere with this study;
* Patients with other conditions not suitable for enrollment as judged by the investigator.

Where it's running

• ChinaPLAGH
  Beijing, Haidian, China Recruiting

Study contacts

• Principal investigator: Yu Zhao, Graduate — Chief
• Study coordinator: Yu Zhao, Graduate
• Email: zhaoyu301@126.com
• Phone: 010-66937232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.