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Recruiting NCT05833893

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

Phase II Interventional nk/T-cell Lymphoma Newly Diagnosed Advanced Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XPO1 inhibitor.
Who it may be relevant to
Registry conditions: nk/T-cell Lymphoma, Newly Diagnosed, Advanced Lymphoma. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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. Initial safety and PET-CT assessment were performed after 3 cycles of treatment (which could be delayed until 4 cycles of treatment in special cases). Patients who achieved partial remission or above will continue the original regimen, and patients who did not achieve partial remission or above will perform re-biopsy and be excluded from the group. Patients who remain partial remission by PET-CT evaluation after 6 cycles may switch to a second-line regimen (referring to NCCN guidelines, GDP regimen combined with selinexor is recommended). Chemotherapy will be performed for up to 8 cycles (followed by autologous or allogeneic hematopoietic stem cell transplantation), after which follow-up period was entered. It is recommended to perform ultrasound or CT evaluation, peripheral blood ctDNA and EBV copy number every three months during the first year of follow-up, and PET-CT evaluation every half a year.

Interventions

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

Primary outcome measures

  • response rate [Time frame: 1-year]
  • Incidence of Treatment-Emergent Adverse Events [Time frame: 1-year]
Secondary outcome measures (3)
  • the 1-year PFS [Time frame: 1-year]
  • the 1-year OS [Time frame: 1-year]
  • the ctDNA and EBV copy number in peripheral blood [Time frame: 1-year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • ChinaPLAGH — Beijing

Publications

  • Benkova K, Mihalyova J, Hajek R, Jelinek T. Selinexor, selective inhibitor of nuclear export: Unselective bullet for blood cancers. Blood Rev. 2021 Mar;46:100758. doi: 10.1016/j.blre.2020.100758. Epub 2020 Sep 15. PMID 32972802
  • Tse E, Kwong YL. Diagnosis and management of extranodal NK/T cell lymphoma nasal type. Expert Rev Hematol. 2016 Sep;9(9):861-71. doi: 10.1080/17474086.2016.1206465. Epub 2016 Jul 8. PMID 27347812
  • Lim SH, Hong JY, Lim ST, Hong H, Arnoud J, Zhao W, Yoon DH, Tang T, Cho J, Park S, Ko YH, Kim SJ, Suh C, Lin T, Kim WS. Beyond first-line non-anthracycline-based chemotherapy for extranodal NK/T-cell lymphoma: clinical outcome and current perspectives on salvage therapy for patients after first relapse and progression of disease. Ann Oncol. 2017 Sep 1;28(9):2199-2205. doi: 10.1093/annonc/mdx316. PMID 28911074

Identifiers

NCT: NCT05833893 · XCOPL - NK/T -P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗