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R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Rituximab

Lenalidomide

Cyclophosphamide

Epirubicin

Vincristine

Prednisone

Methotrexate

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring Diffuse Large B Cell Lymphoma, R-CHOP, Lenalidomide

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 18 to 70 years old (including 18 and 70)
Diagnosed as diffuse large B cell lymphoma
Subjects must be untreated (medium to high risk/high risk: International Prognostic Index (IPI) score 3-5, aaIPI score 2-3 or NCCN-IPI score≥ 4/ Immunohistochemical staining of double expression (BCL2 ≥ 70% and C-MYC ≥ 40%) or P53 protein mutation positive ≥ 50%)
No receiving chemotherapy before enrollment
Having at least one measurable lesions
World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
Life expectancy no less than 3 months
enough main organ function
Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
Agreeing to sign the written informed consents

Exclusion Criteria:

Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike
Diagnosed as grey-zone lymphoma
Diagnosed as central nervous system lymphoma
Diagnosed as primary mediastinal large B-cell lymphoma
Diagnosed as CD20 negative diffuse large B-cell lymphoma
Other malignant tumor history or active malignant tumor need be treated
Serious surgery and trauma less than two weeks
Systemic therapy for serious acute/chronic infection
Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
Vaccination with live attenuated vaccine less than 4 weeks
HIV-positive, AIDS patients and untreated active hepatitis
Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
Patients with a history of mental illness
Researchers determine unsuited to participate in this trial

Sites / Locations

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-CHOP regimen Combined With Lenalidomide

Arm Description

Experimental: R-CHOP regimen Combined With Lenalidomide Induction Chemotherapy: Rituximab, 375mg/m2, Intravenous administration on day 0, Lenalidomide, 25mg oral administration on day 1 to 10, combined with regimen：CHOP (Cyclophosphamide, Epirubicin, Vincristine and Prednisone): repeated every 3 weeks, up to 6 cycles. PS: Methotrexate, 3g/m2, Intravenous administration on day 3 of each 3-week cycle, from 2 to 5 cycles for patients with high recurrence risk of the central nervous system. Maintenance Treatment: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 4 weeks, up to 2 cycles; Lenalidomide, 10mg oral administration on day 1 to 21 repeated every 4 weeks, up to 12 cycles.

Outcomes

Primary Outcome Measures

2-year progression-free survival

the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

Secondary Outcome Measures

objective response rate

the total proportion of patients with complete response (CR) and partial response (PR)

2-year overall survival

from date of first day of treatment to the date of death by any cause

incidence and relationship with study drugs of grade 3-4 adverse events

the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)

Full Information

NCT ID

NCT04214626

First Posted

December 26, 2019

Last Updated

October 5, 2023

Sponsor

Henan Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04214626

Brief Title

R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma

Official Title

A Single Arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 2, 2020 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and Prednisone) combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

Detailed Description

Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma (NHL). Currently, R-CHOP is world-widely used in the first-line treatment for DLBCL. There are about one second of patients suffering relapse and drug resistance. Lenalidomide is an analog of thalidomide, the mechanism of anti-tumor action has not been fully elucidated. Lenalidomide has been proved to inhibit the proliferation of tumor cells in certain hematopoietic systems. At present, it has been approved for the treatment of multiple myeloma with good efficacy and safety. The goal of our trial is to assess the efficacy and safety of R-CHOP combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B Cell Lymphoma, R-CHOP, Lenalidomide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

R-CHOP regimen Combined With Lenalidomide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

RiTUXimab Injection

Intervention Description

Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles. Maintenance Treatment: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 2 cycles.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Lenalidomide capsule

Intervention Description

Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles. Maintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Cyclophosphamide Injection

Intervention Description

Induction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Other Intervention Name(s)

Epirubicin hydrochloride

Intervention Description

Induction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Vincristine

Other Intervention Name(s)

Vincristine Injection

Intervention Description

Induction Chemotherapy: 1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

Prednisone Oral Product

Intervention Description

Induction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Other Intervention Name(s)

Methotrexate Injectable Solution

Intervention Description

Induction Chemotherapy: 3g/m2, Intravenous administration on day 3 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, from 2 to 5 cycles for patients with high recurrence risk of the central nervous system.

Primary Outcome Measure Information:

Title

2-year progression-free survival

Description

the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

Time Frame

from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment

Secondary Outcome Measure Information:

Title

objective response rate

Description

the total proportion of patients with complete response (CR) and partial response (PR)

Time Frame

every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment

Title

2-year overall survival

Description

from date of first day of treatment to the date of death by any cause

Time Frame

from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years

Title

incidence and relationship with study drugs of grade 3-4 adverse events

Description

the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)

Time Frame

from the date of the first cycle of treatment to 18 months after last patient's enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18 to 70 years old (including 18 and 70) Diagnosed as diffuse large B cell lymphoma Subjects must be untreated (medium to high risk/high risk: International Prognostic Index (IPI) score 3-5, aaIPI score 2-3 or NCCN-IPI score≥ 4/ Immunohistochemical staining of double expression (BCL2 ≥ 70% and C-MYC ≥ 40%) or P53 protein mutation positive ≥ 50%) No receiving chemotherapy before enrollment Having at least one measurable lesions World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 Life expectancy no less than 3 months enough main organ function Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study Agreeing to sign the written informed consents Exclusion Criteria: Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike Diagnosed as grey-zone lymphoma Diagnosed as central nervous system lymphoma Diagnosed as primary mediastinal large B-cell lymphoma Diagnosed as CD20 negative diffuse large B-cell lymphoma Other malignant tumor history or active malignant tumor need be treated Serious surgery and trauma less than two weeks Systemic therapy for serious acute/chronic infection Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months Vaccination with live attenuated vaccine less than 4 weeks HIV-positive, AIDS patients and untreated active hepatitis Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months Patients with a history of mental illness Researchers determine unsuited to participate in this trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanyan Liu, M.D. Ph.D

Phone

+8613818176375

yyliu@zzu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanyan Liu, M.D. Ph.D

Organizational Affiliation

Henan Cancer Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanyan Liu, M.D. Ph.D

Phone

+8613838176375

yyliu@zzu.edu.cn

First Name & Middle Initial & Last Name & Degree

Yanyan Liu, M.D. Ph.D

12. IPD Sharing Statement

Learn more about this trial

R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma

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