RecruitingPhase 2NCT05833893

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


Sponsor

Chinese PLA General Hospital

Enrollment

10 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 14 Years

Inclusion Criteria9

  • 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 Criteria8

  • 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.

Interventions

DRUGXPO1 inhibitor

COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)


Locations(1)

ChinaPLAGH

Beijing, Haidian, China

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NCT05833893


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