NCT05833893RecruitingPhase 2
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
Source: ClinicalTrials.gov · Last updated 27 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 25 Feb 2023
- Start date
- 1 May 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT05833893
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From 1 May 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic HCT (allo-HCT)
Other illness
- Active autoimmune disease
- 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.
Other
- Primary central nervous system lymphoma;
Who the study is looking for
- 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
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ChinaPLAGH Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.