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

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ClinicalTrials.gov Identifier: NCT05923879
Recruitment Status : Not yet recruiting
First Posted : June 28, 2023
Last Update Posted : June 28, 2023
Sponsor:
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Lymphoma, Large B-Cell, Diffuse Drug: Selinexor combined with lenalidomide and rituximab

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Mechanism Investigation of Selinexor Combined With Lenalidomide and Rituximab in the Treatment of Diffuse Large B-cell Lymphoma
Estimated Study Start Date : June 30, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Intervention Details:
  • Drug: Selinexor combined with lenalidomide and rituximab
    Selinexor combined with lenalidomide and rituximab

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923879


Locations
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China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Contact: Weili Zhao       zwl_trial@163.com   
Sponsors and Collaborators
Ruijin Hospital
More Information
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Responsible Party: Zhao Weili, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT05923879    
Other Study ID Numbers: SR2-DLBCL
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: June 28, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
 Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors