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

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05923879
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	Phase
Lymphoma, Large B-Cell, Diffuse	Drug: Selinexor combined with lenalidomide and rituximab

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Study Start Date: Jun 30, 2023
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Outcome Measures

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai		China

Sponsors and Collaborators

• Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhao Weili, Professor, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT05923879
• Other Study ID Numbers: SR2-DLBCL
• First Posted: Jun 28, 2023
• Last Update Posted: Jun 28, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse; Rituximab; Lenalidomide

Study Results

No Results Posted as of Jun 28, 2023