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

Chinese PLA General Hospital (301 Hospital)

Status and phase

Enrolling

Phase 2

Conditions

Newly Diagnosed

nk/T-cell Lymphoma

Advanced Lymphoma

Treatments

Drug: XPO1 inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT05833893

XCOPL - NK/T -P01

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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.