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

NCT ID: NCT05833893

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

XPO1 inhibitor

Intervention Type: DRUG

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

Interventions

XPO1 inhibitor

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

Intervention Type: DRUG

Other Intervention Names

COPL

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu Zhao

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Zhao, Graduate

Role: PRINCIPAL_INVESTIGATOR

Chief

Sai Huang, Graduate

Role: PRINCIPAL_INVESTIGATOR

Attending doctor

Locations

ChinaPLAGH

Beijing, Haidian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Zhao, Graduate

Role: CONTACT

zhaoyu301@126.com

010-66937232

Sai Huang, Graduate

Role: CONTACT

helinahs@qq.com

010-66937232

Facility Contacts

Yu Zhao, Graduate

Role: primary

010-66937232

Sai Huang, Graduate

Role: backup

010-66937232

References

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.

Reference Type: RESULT

PMID: 32972802 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27347812 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28911074 (View on PubMed)

Other Identifiers

XCOPL - NK/T -P01

Identifier Type: -

Identifier Source: org_study_id