A Real-world Study of Selinexor-based Regimens for Treatment of Non-Hodgkin Lymphoma

Study Overview
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Brief Summary
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This study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma

Detailed Description
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this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with DLBCL or T cell lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Official Title
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A Real-world Study: Efficacy and Safety of Selinexor-based Regimens for Non-Hodgkin Lymphoma

Conditions
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Lymphoma, DLBCL, T Cell Lymphoma

Intervention / Treatment
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* Drug: Selinexor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Know and voluntarily sign the Informed Consent Form (ICF) Clinically confirmed DLBCL, T or NK cell lymphoma Patients with DLBCL or T or NK cell lymphoma who have used selinexor-based therapy in the past 3 months are included Cooperate with clinical diagnosis and treatment management, and provide disease-related past medical history materials Exclusion Criteria: Previously received selinexor Poor patient compliance physicians evaluate that patients are not suitable for enrollment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| selinexor-based regimens<br>This study is a real-world study to explore the safety and efficacy of selinexor-based therapy in patients with lymphoma. It is planned to enroll 250 patients with lymphoma, including 150 patients with diffuse large B-cell lymphoma and 100 patients with peripheral T and NK/T-cell lymphoma. | Drug: Selinexor<br>* this is a real-world. Patients who use selinexor-based regimens in lymphoma will be followed up without interfering with the choice of treatment options for patients<br>* Other names: XPO1 inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) | the percentage of patients with complete response and partial response | throughout the study, an average of 1 year | 
| incidence of adverse events/ serious adverse events | identify patterns of incidence in adverse events | throughout the study, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of dose delays or interruptions | calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall | throughout the study, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SELINEXOR, LYMPHOMA