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

Advanced Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833893
• Other study ID #: XCOPL - NK/T -P01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Chinese PLA General Hospital
• Contact: Yu Zhao, Graduate
• Phone: 010-66937232
• Email: zhaoyu301[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Advanced Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Newly Diagnosed
• nk/T-cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	ChinaPLAGH	Beijing	Haidian

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & 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. — 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

Outcome

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