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New treatment option for nk/T-cell Lymphoma
Official title Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
ClinicalTrials.gov ID: NCT05833893
What this study is testing
What is XPO1 inhibitor?
XPO1 inhibitor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nk/t-cell lymphoma.
Also referred to as COPL.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join 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...
- ECOG score 0\~2;
- Clinical stage III\~IV;
You likely can't join 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;
See the full eligibility 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...
- Expected survival \> 6 months
- Agree to use effective contraception;
- Understand and voluntarily sign written informed consent
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Haidian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Haidian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.