Treatment of advanced NK/T-cell lymphoma with selinexor and chemotherapy
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
This study tests if adding a new drug called selinexor to standard chemotherapy can help people with advanced NK/T-cell lymphoma feel better and improve their treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Beijing, Haidian) |
| Trial ID | NCT05833893 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of the XPO1 inhibitor selinexor combined with the XCOPL chemotherapy regimen in patients with newly diagnosed, pathologically confirmed advanced NK/T-cell lymphoma. Participants will undergo treatment cycles lasting three weeks each, with a total of 6-8 cycles planned. Safety assessments and PET-CT evaluations will be conducted to monitor treatment response, and those achieving partial remission may switch to a second-line regimen. The study aims to improve outcomes for patients with this aggressive form of lymphoma.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 and older with newly diagnosed, pathologically confirmed stage III-IV NK/T-cell lymphoma.
Not a fit: Patients with prior allogeneic hematopoietic cell transplantation or active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve remission rates and overall survival for patients with advanced NK/T-cell lymphoma.
How similar studies have performed: While there have been studies on NK/T-cell lymphoma treatments, the combination of selinexor with the XCOPL regimen represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Haidian
- ChinaPLAGH — Beijing, Haidian, China (Recruiting)
Study contacts
- Principal investigator: Yu Zhao, Graduate — Chief
- Study coordinator: Yu Zhao, Graduate
- Email: zhaoyu301@126.com
- Phone: 010-66937232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.