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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05852028
• Other study ID #: RJ-XLYM-001
• Status: Recruiting
• Start date: December 15, 2022
• Est. completion date: October 18, 2025

Study information

• Verified date: May 2023
• Source: Ruijin Hospital
• Contact: Weili Zhao, Prof.
• Phone: +862164370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 18, 2025
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• DLBCL
• Lymphoma
• Lymphoma, Non-Hodgkin
• T Cell Lymphoma

Intervention

Drug:
• Selinexor
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

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of response (DOR)	DOR is calculated as the time from initial response (complete response or partial response) to date of progression or death, whichever is earlier	throughout the study, an average of 2 year
Primary	Objective response rate(ORR)	the percentage of patients with complete response and partial response	throughout the study, an average of 1 year
Primary	incidence of adverse events/ serious adverse events	identify patterns of incidence in adverse events	throughout the study, an average of 2 year
Secondary	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