Mechanism Investigation of Selinexor Combined With Lenalidomide and Rituximab in the Treatment of Diffuse Large B-cell Lymphoma

June 20, 2023 updated by: Zhao Weili, Ruijin Hospital
This is a retrospective observational study of the therapeutic mechanism and resistance mechanism of the treatment of Selinexor combined with lenalidomide and rituximab in diffuse large B-cell lymphoma patients. By detecting the immune cells in peripheral blood and tumor tissues of patients before and after treatment, the key immune cell subsets and immune molecules linked to the action and resistance of the treatment of Selinexor combined with lenalidomide and rituximab, so as to provide the basis for the optimization of the treatment or the combination of other immunotherapies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

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

Study Locations

  • China
      • Shanghai, China
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Over 18-year-old recurrent or refractory diffuse large B-cell lymphoma patients receiving Selinexor combined with lenalidomide and rituximab would be enrolled.

Description

Inclusion Criteria:

  1. At least 18 years old.
  2. Histopathologically confirmed diffuse large B-cell lymphoma according to World Health Organization (WHO) classification criteria 2016.
  3. There is evidence of relapsed or refractory disease.
  4. Treatment with Selinexor combined with lenalidomide and rituximab.

Exclusion Criteria:

  • No

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor tissues collected before treatment and at the point of progression if available for DNA sequencing after quality control.
Time Frame: 2023/06/30-2025/06/30
Tumor tissues collected before treatment and at the point of progression if available for DNA sequencing after quality control. On the one hand, the difference of tumor mutations will be analyzed in pre-treatment biopsy samples of patients grouped by efficacy; on the other hand, the changes of tumor mutations will be analyzed between pre-treatment and post-treatment biopsy samples of patients.
2023/06/30-2025/06/30
Tumor tissues collected before treatment and at the point of progression if available for RNA sequencing after quality control.
Time Frame: 2023/06/30-2025/06/30
Tumor tissues collected before treatment and at the point of progression if available for bulky RNA sequencing, single-cell RNA sequencing and spatial transcriptome sequencing after quality control. On the one hand, the difference of characteristics of tumor microenvironment will be analyzed in pre-treatment biopsy samples of patients grouped by efficacy; on the other hand, the changes of characteristics of tumor microenvironment will be analyzed between pre-treatment and post-treatment biopsy samples of patients.
2023/06/30-2025/06/30
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Time Frame: 2023/06/30-2025/06/30
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and chemokines and cytokines.
2023/06/30-2025/06/30

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 (Estimated)

June 30, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 3, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR2-DLBCL

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

Yes

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.

Clinical Trials on Lymphoma, Large B-Cell, Diffuse

Clinical Trials on Selinexor combined with lenalidomide and rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe