Advanced Lymphoma Clinical Trial
Official title:
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | ChinaPLAGH | Beijing | Haidian |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
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. — View Citation
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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate | complete remission + partial remission | 1-year | |
Primary | Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | 1-year | |
Secondary | the 1-year PFS | To evaluate the 1-year PFS of XCOPL regimen in advanced NK/T-cell lymphoma | 1-year | |
Secondary | the 1-year OS | To evaluate the 1-year OS of XCOPL regimen in advanced NK/T-cell lymphoma | 1-year | |
Secondary | the ctDNA and EBV copy number in peripheral blood | To evaluate the feasibility of measurable residual disease (MRD) detection and clinical recurrence prediction by ctDNA and EBV copy number. | 1-year |
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