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The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Six Courses of R-CHOP Plus Two Courses of Rituximab

Four Courses of R-CHOP Plus Four Courses of Rituximab

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring Diffuse large B cell lymphoma, Side effects, Rituximab

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2)
Treatment naïve
IPI=0,1
Age ≥ 14 or ≤75 years
non-mass (The length of the lesion<7.5cm)
ECOG=0,1
Life expectancy>6 months
Informed consented

Exclusion Criteria:

Have received systemic or local treatment including chemotherapy in the past
Have received autologous stem cell transplantation in the past
Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ
Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases
Primary skin, primary central nervous system lymphoma
Left ventricular ejection fraction ≦50%
Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision
Laboratory test value during screening: (unless it is caused by lymphoma) Neutrophils <1.5*109/L Platelet<80*109/L Hemoglobin <100g/L ALT or AST is 2 times higher than the upper limit of normal, AKP and bilirubin are 1.5 times higher than the upper limit of normal E. Creatinine level is higher than 1.5 times the upper limit of normal
Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol
Pregnant or lactating women
Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group
Patients living with HIV
Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

4RCHOP+4R

6RCHOP+2R

Arm Description

Four Courses of R-CHOP Plus Four Courses of Rituximab

Six Courses of R-CHOP Plus Two Courses of Rituximab

Outcomes

Primary Outcome Measures

Progression of disease within 24 months

Progression of disease within 24 months was defined as the rate of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Secondary Outcome Measures

Overall response rate

Percentage of participants with overall response examined by PET-CT was determined on the basis of investigator assessments according to 2014 Lugano criteria

Overall survival

Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events

Quality of life of patients

Quality of life of patients estimated by European organization for Research and Treatment of Cancer (EORCT) QLQ一C30 by the researchers

Full Information

NCT ID

NCT05018520

First Posted

August 11, 2021

Last Updated

May 27, 2023

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05018520

Brief Title

The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk

Official Title

The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2021 (Actual)

Primary Completion Date

September 15, 2025 (Anticipated)

Study Completion Date

September 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin 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

Detailed Description

Diffuse large B cell lymphoma (DLBCL) is the subtype with the highest incidence, accounting for 35.8% of B cell lymphoma. 6 to 8 cycles of R-CHOP regimen is currently the standard first-line regimen for DLBCL, however, the side effects including nausea, vomiting, neutropenia, hair loss, and heart failure can decrease the life quality and are sometimes life threatening. Recently, domestic and foreign scholars have been committed to reduce the dose of chemotherapy and improve the quality of life in low-risk patients. This study uses 4 courses of R-CHOP plus 4 courses of R (4+4 plan) versus 6 courses of R-CHOP plus 2 courses of R (6+2 plan) for the treatment of newly treated, low-risk, non-mass DLBCL patients. The promising result will create a new model for the treatment and improve the life quality of low-risk DLBCL.

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, Side effects, Rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

4RCHOP+4R

Arm Type

Experimental

Arm Description

Four Courses of R-CHOP Plus Four Courses of Rituximab

Arm Title

6RCHOP+2R

Arm Type

Experimental

Arm Description

Six Courses of R-CHOP Plus Two Courses of Rituximab

Intervention Type

Drug

Intervention Name(s)

Six Courses of R-CHOP Plus Two Courses of Rituximab

Intervention Description

The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 21 days for total 2 courses)

Intervention Type

Drug

Intervention Name(s)

Four Courses of R-CHOP Plus Four Courses of Rituximab

Intervention Description

The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 4 courses) followed by Rituximab (375mg/m2 d1, every 21 days for total 4 courses)

Primary Outcome Measure Information:

Title

Progression of disease within 24 months

Description

Progression of disease within 24 months was defined as the rate of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Time Frame

Baseline up to data cut-off (up to approximately 24 months)

Secondary Outcome Measure Information:

Title

Overall response rate

Description

Percentage of participants with overall response examined by PET-CT was determined on the basis of investigator assessments according to 2014 Lugano criteria

Time Frame

t the end of Cycle 8 (each cycle is 21 days)

Title

Overall survival

Description

Time Frame

Baseline up to data cut-off (up to approximately 2 years)

Title

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Description

Time Frame

Up to 30 days after completion of study treatment

Title

Quality of life of patients

Description

Quality of life of patients estimated by European organization for Research and Treatment of Cancer (EORCT) QLQ一C30 by the researchers

Time Frame

Up to 30 days after completion of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2) Treatment naïve IPI=0,1 Age ≥ 14 or ≤75 years non-mass (The length of the lesion<7.5cm) ECOG=0,1 Life expectancy>6 months Informed consented Exclusion Criteria: Have received systemic or local treatment including chemotherapy in the past Have received autologous stem cell transplantation in the past Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases Primary skin, primary central nervous system lymphoma Left ventricular ejection fraction ≦50% Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision Laboratory test value during screening: (unless it is caused by lymphoma) Neutrophils <1.5*109/L Platelet<80*109/L Hemoglobin <100g/L ALT or AST is 2 times higher than the upper limit of normal, AKP and bilirubin are 1.5 times higher than the upper limit of normal E. Creatinine level is higher than 1.5 times the upper limit of normal Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol Pregnant or lactating women Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group Patients living with HIV Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening

Central Contact Person:

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

Weili Zhao

Phone

+862164370045

Ext

610707

zwl_trial@163.com

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

Pengpeng Xu

Phone

+862164370045

Ext

610707

pengpeng_xu@126.com

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weili Zhao

Phone

+862164370045

Ext

610707

zwl_trial@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk

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