🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05833893
Recruiting Phase 2

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

NCT05833893 · tracked via the Priya Life Science China tracker
Sponsor
Chinese PLA General Hospital
Phase
Phase 2
Started
2023-05-01
Last updated
2023-04-27

Condition(s) studied

nk/T-cell LymphomaNewly DiagnosedAdvanced Lymphoma

Investigational drug(s) / intervention(s)

XPO1 inhibitor

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

Study 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

Sex
ALL
Min age
14 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
ChinaPLAGH Beijing Haidian Recruiting

More Chinese PLA General Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05833893 on ClinicalTrials.gov ↗ ← All trials in China