Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
Recruiting now · Phase 2
Conditions studied: nk/T-cell Lymphoma, Newly Diagnosed, Advanced Lymphoma
In brief
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.
Key facts
- Study ID
- NCT05833893
- Run by
- Chinese PLA General Hospital
- People needed
- 10
- Starts
- 2023-05-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2023-04-27
Who can join
Age: 14 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- ChinaPLAGH — Beijing, Haidian, China (enrolling)
Full record on ClinicalTrials.gov
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