A Real-world Study of Selinexor-based Regimens for Treatment of Non-Hodgkin Lymphoma
- Registration Number
- NCT05852028
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
This study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- Previously received selinexor
- Poor patient compliance
- physicians evaluate that patients are not suitable for enrollment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description selinexor-based regimens Selinexor 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.
- Primary Outcome Measures
Name Time Method Objective response rate(ORR) throughout the study, an average of 1 year the percentage of patients with complete response and partial response
incidence of adverse events/ serious adverse events throughout the study, an average of 2 year identify patterns of incidence in adverse events
- Secondary Outcome Measures
Name Time Method incidence of dose delays or interruptions throughout the study, an average of 2 year calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall
Trial Locations
- Locations (3)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Union Hospital Affiliated to Huazhong University of Science and Technology
🇨🇳Wuhan, China