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

NCT05852028 | Unknown

• 1 other identifier: RJ-XLYM-001
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Lymphoma; DLBCL; T Cell Lymphoma

Keywords

SELINEXOR; LYMPHOMA

Outcome Measures

Primary Outcomes (2)

• Objective response rate(ORR)

  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

  identify patterns of incidence in adverse events

  throughout the study, an average of 2 year

Secondary Outcomes (1)

• incidence of dose delays or interruptions

  throughout the study, an average of 2 year

Other Outcomes (1)

• duration of response (DOR)

  throughout the study, an average of 2 year

Study Arms (1)

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

Interventions

Selinexor DRUG

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

Also known as: XPO1 inhibitor

selinexor-based regimens

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

DLBCL, T or NK cell lymphoma

You may qualify if:

• 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

You may not qualify if:

• Previously received selinexor
• Poor patient compliance
• physicians evaluate that patients are not suitable for enrollment

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (3)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Union Hospital Affiliated to Huazhong University of Science and Technology

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Lymphoma, T-Cell

Interventions

selinexor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Central Study Contacts

Weili Zhao, Prof.

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu, Prof.

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: May 10, 2023
• Study Start: December 15, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 18, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

CN (3)