## Protocol Section
### Identification Module
**NCT ID:** NCT05923879

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

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

#### Organization Study ID Info
**ID:** SR2-DLBCL
#### Organization
**Class:** OTHER
**Full Name:** Ruijin Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-28

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2023-06-28
**Type:** ACTUAL
**Study First Submit Date:** 2023-06-03
**Study First Submit QC Date:** 2023-06-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ruijin Hospital

#### Responsible Party

**Investigator Affiliation:** Ruijin Hospital

**Investigator Full Name:** Zhao Weili

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**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 Module

**Conditions:**

- Lymphoma, Large B-Cell, Diffuse

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Selinexor combined with lenalidomide and rituximab

**Name:** Selinexor combined with lenalidomide and rituximab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** zwl_trial@163.com

- **Name:** Weili Zhao

- **Role:** CONTACT

**Country:** China

**Facility:** Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000016393

- Term: Lymphoma, B-Cell

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M18831

- Name: Lymphoma, Large B-Cell, Diffuse

- Relevance: HIGH

- As Found: Lymphoma, Large B-Cell, Diffuse

- ID: M18828

- Name: Lymphoma, B-Cell

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T640

- Name: B-cell Lymphoma

- Relevance: HIGH

- As Found: B-cell Lymphoma

- ID: T1866

- Name: Diffuse Large B-Cell Lymphoma

- Relevance: HIGH

- As Found: Diffuse Large B-Cell Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000016403

- Term: Lymphoma, Large B-Cell, Diffuse

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000006131

- Term: Growth Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M373

- Name: Rituximab

- Relevance: HIGH

- As Found: Healthy

- ID: M1725

- Name: Lenalidomide

- Relevance: HIGH

- As Found: Respiratory

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069283

- Term: Rituximab

- ID: D000077269

- Term: Lenalidomide

### Misc Info Module

- Version Holder: 2024-05-24
