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

NCT05923879 | Unknown FDA Drug

• 1 other identifier: SR2-DLBCL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma, Large B-Cell, Diffuse

Outcome Measures

Primary Outcomes (3)

• Tumor tissues collected before treatment and at the point of progression if available for DNA sequencing after quality control.

  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.

  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.

  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

Interventions

Selinexor combined with lenalidomide and rituximab DRUG

Selinexor combined with lenalidomide and rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2023
• First Posted: June 28, 2023
• Study Start: June 30, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

CN (1)