Actively Recruiting

Phase 2
Age: 14Years +
All Genders
NCT05833893

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

Led by Chinese PLA General Hospital · Updated on 2023-04-27

10

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 years or older, any gender
  • Newly diagnosed NK/T-cell lymphoma confirmed by pathology according to WHO 2016 criteria
  • At least one measurable lesion: lymph node lesion > 1.5 cm or extranodal lesion > 1.0 cm in short axis
  • ECOG performance score between 0 and 2
  • Clinical stage III or IV lymphoma
  • Normal major organ function including: WBC ≥ 3.5 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 80 g/L
  • Liver function: AST and ALT ≤ 3 times upper limit of normal; total bilirubin ≤ 2.0 mg/dL
  • Kidney function: creatinine clearance ≥ 60 mL/min; liver or kidney impairment due to tumor compression allowed
  • Normal fibrinogen at first treatment cycle
  • Expected survival longer than 6 months
  • Agree to use effective contraception
  • Able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Prior allogeneic hematopoietic cell transplantation
  • Active autoimmune disease
  • Primary central nervous system lymphoma
  • Current infection requiring treatment (re-enrollment possible after infection is controlled)
  • Known HIV infection
  • Known allergy to study drug or its ingredients
  • Other active cancers requiring treatment that may interfere with study
  • Any other condition making participation unsuitable as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

ChinaPLAGH

Beijing, Haidian, China, 100853

Actively Recruiting

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Research Team

Y

Yu Zhao, Graduate

CONTACT

S

Sai Huang, Graduate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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