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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05852028
Other study ID # RJ-XLYM-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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