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

NCT05833893 | Recruiting Phase 2

• 1 other identifier: XCOPL - NK/T -P01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

nk/T-cell Lymphoma; Newly Diagnosed; Advanced Lymphoma

Outcome Measures

Primary Outcomes (2)

• response rate

  complete remission + partial remission

  1-year

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  1-year

Secondary Outcomes (3)

• the 1-year PFS

  1-year

• the 1-year OS

  1-year

• the ctDNA and EBV copy number in peripheral blood

  1-year

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Drug: XPO1 inhibitor

Interventions

XPO1 inhibitor DRUG

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

Also known as: COPL

Treatment group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

ChinaPLAGH

Beijing, Haidian, 100853, China

RECRUITING

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yu Zhao, Graduate

  Chief

  PRINCIPAL INVESTIGATOR

• Sai Huang, Graduate

  Attending doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Zhao, Graduate

CONTACT

010-66937232; zhaoyu301@126.com

Sai Huang, Graduate

CONTACT

010-66937232; helinahs@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: April 27, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)