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

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05852028
Collaborator
(none)
250
Enrollment
3
Locations
34.1
Anticipated Duration (Months)
83.3
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Real-world Study: Efficacy and Safety of Selinexor-based Regimens for Non-Hodgkin Lymphoma
Actual Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Oct 10, 2024
Anticipated Study Completion Date :
Oct 18, 2025

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate(ORR) [throughout the study, an average of 1 year]

      the percentage of patients with complete response and partial response

    2. 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

    1. 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

    Other Outcome Measures

    1. duration of response (DOR) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200025
    2 The First Affiliated Hospital of Soochow University Suzhou China
    3 Union Hospital Affiliated to Huazhong University of Science and Technology Wuhan China

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhao Weili, Prof., Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT05852028
    Other Study ID Numbers:
    • RJ-XLYM-001
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhao Weili, Prof., Ruijin Hospital
    SELINEXOR
    LYMPHOMA
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin

    Study Results

    No Results Posted as of May 10, 2023