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

Launched by CHINESE PLA GENERAL HOSPITAL · Apr 18, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients who have recently been diagnosed with advanced NK/T-cell lymphoma, a type of cancer that affects the immune system. The study is testing a combination of a medication called Selinexor with a treatment regimen known as COPL. Participants will receive this treatment in cycles, lasting three weeks for each cycle, and they may go through a total of 6 to 8 cycles.

To be eligible for this trial, participants need to be at least 14 years old and have been diagnosed with stage III or IV NK/T-cell lymphoma that can be measured. They should also have normal organ function and be in good health overall. If someone joins the trial, they can expect regular check-ups and monitoring throughout the treatment process. It's important to know that this trial is currently recruiting participants, so there may be opportunities for those who qualify to receive this promising new therapy.

Gender

ALL

Eligibility criteria

• 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.