Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma

Summary

Patients with newly diagnosed, pathologically confirmed NK/T-cell lymphoma of stage III-IV treated with XCOPL regimen. 3 weeks for a cycle, with a total of 6-8 cycles.

Eligibility

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.

Conditions4

Browse More Trials