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

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05833893
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
44
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: XPO1 inhibitor
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. response rate [1-year]

      complete remission + partial remission

    2. Incidence of Treatment-Emergent Adverse Events [1-year]

      Incidence of Treatment-Emergent Adverse Events

    Secondary Outcome Measures

    1. the 1-year PFS [1-year]

      To evaluate the 1-year PFS of XCOPL regimen in advanced NK/T-cell lymphoma

    2. the 1-year OS [1-year]

      To evaluate the 1-year OS of XCOPL regimen in advanced NK/T-cell lymphoma

    3. the ctDNA and EBV copy number in peripheral blood [1-year]

      To evaluate the feasibility of measurable residual disease (MRD) detection and clinical recurrence prediction by ctDNA and EBV copy number.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ChinaPLAGH Beijing Haidian China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    • Principal Investigator: Yu Zhao, Graduate, Chief
    • Principal Investigator: Sai Huang, Graduate, Attending doctor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yu Zhao, Chief physician, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT05833893
    Other Study ID Numbers:
    • XCOPL - NK/T -P01
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral

    Study Results

    No Results Posted as of Apr 27, 2023