NCT05833893 Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
| NCT ID | NCT05833893 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | nk/T-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2023-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Yu Zhao, Graduate
PRINCIPAL INVESTIGATOR
Chief
Frequently Asked Questions
Who can join the NCT05833893 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying nk/T-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05833893 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05833893 currently recruiting?
Yes, NCT05833893 is actively recruiting participants. Contact the research team at zhaoyu301@126.com for enrollment information.
Where is the NCT05833893 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05833893 clinical trial?
NCT05833893 is sponsored by Chinese PLA General Hospital. The principal investigator is Yu Zhao, Graduate at Chief. The trial plans to enroll 10 participants.