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

May 9, 2023 updated by: Zhao Weili, Ruijin Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Weili Zhao, Prof.
  • Phone Number: 610707 +862164370045
  • Email: zwl_trial@163.com

Study Contact Backup

Study Locations

  • China
      • Suzhou, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Depei Wu, Prof.
      • Wuhan, China
        • Recruiting
        • Union Hospital affiliated to Huazhong University of Science and Technology
        • Contact:
          • Yu Hu, Prof.
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

DLBCL, T or NK cell lymphoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
selinexor-based regimens
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
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
Other Names:
  • XPO1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)
Time Frame: throughout the study, an average of 1 year
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
Time Frame: throughout the study, an average of 2 year
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
Time Frame: throughout the study, an average of 2 year
calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall
throughout the study, an average of 2 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of response (DOR)
Time Frame: throughout the study, an average of 2 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Anticipated)

October 10, 2024

Study Completion (Anticipated)

October 18, 2025

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ-XLYM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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