## Protocol Section
### Identification Module
**NCT ID:** NCT04622579

**Acronym:** R2DLBCL80

**Brief Title:** Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years

**Official Title:** Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma

#### Organization Study ID Info
**ID:** 2020099H
#### Organization
**Class:** OTHER
**Full Name:** Guangdong Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2023-03-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-11-10

**Type:** ACTUAL

**Last Update Submit Date:** 2020-11-05

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-10-23

**Type:** ACTUAL

**Status Verified Date:** 2020-11

#### Study First Post Date
**Date:** 2020-11-10
**Type:** ACTUAL
**Study First Submit Date:** 2020-11-05
**Study First Submit QC Date:** 2020-11-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Guangzhou First People's Hospital

**Class:** OTHER

**Name:** First People's Hospital of Foshan

**Class:** OTHER

**Name:** Huizhou Municipal Central Hospital

**Class:** OTHER

**Name:** Shantou Central Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Guangdong Provincial People's Hospital

#### Responsible Party

**Investigator Affiliation:** Guangdong Provincial People's Hospital

**Investigator Full Name:** Wenyu Li

**Investigator Title:** professor of medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.

### Conditions Module

**Conditions:**

- Diffuse Large B Cell Lymphoma

- Age Over 80 Years

**Keywords:**

- lenalidomide

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.

**Intervention Names:**

- Drug: lenalidomide combined with rituximab

**Label:** lenalidomide combined with rituximab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- lenalidomide combined with rituximab

**Description:** lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.

**Name:** lenalidomide combined with rituximab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Overall response rate

**Measure:** ORR

**Time Frame:** 24 months

#### Secondary Outcomes

**Description:** Complete response

**Measure:** CR

**Time Frame:** 24 months

**Description:** Overall survival

**Measure:** OS

**Time Frame:** from date of treatment until the date of death from any cause, assessed up to 5 years

**Description:** Progression-free survival

**Measure:** PFS

**Time Frame:** from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age≧80 years ;
2. ECOG score 0-2；
3. untreated with pathologically conﬁrmed CD20+ DLBCL ;
4. expected life expectancy of ≥ 12 weeks;
5. capable of swallowing tablets;
6. GFR(by Cockcroft- Gault)≥30 ml/min;
7. can sign written informed consent to participate in the study.

Exclusion Criteria:

1. with CNS involvement;
2. with other malignancy (not including adequate-treated non-melanoma cutaneum carcinoma); patients with other cancer but disease-free for ≥5 years can enter this study;
3. with ≥ grade 2 peripheral neurophathy;
4. with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;
5. received live vaccine within 28 days.;
6. HIV-positive;
7. thrombosis ;
8. GFR\<30 mL/min;
9. other conditions not suitable for rituximab or lenalidomide application.

**Minimum Age:** 80 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 296260860@qq.com

**Name:** Xinmiao Jiang

**Phone:** （+86）20-83827812

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** 296260860@qq.com

- **Name:** Xinmiao Jiang

- **Phone:** +86 20 81884713-80631

- **Role:** CONTACT

**Country:** China

**Facility:** Guangdong provincial people's hospital

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510080

## 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: 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: Diffuse Large B-Cell Lymphoma

- ID: M18828

- Name: Lymphoma, B-Cell

- Relevance: HIGH

- As Found: B-cell Lymphoma

- 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: LOW

- As Found: Unknown

- 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: D000016393

- Term: Lymphoma, B-Cell

- 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
