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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4RCHOP+4R | Experimental | Four Courses of R-CHOP Plus Four Courses of Rituximab |
|
| 6RCHOP+2R | Experimental | Six Courses of R-CHOP Plus Two Courses of Rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Six Courses of R-CHOP Plus Two Courses of Rituximab | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to data cut-off (up to approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | t the end of Cycle 8 (each cycle is 21 days) |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao | Contact | +862164370045 | 610707 | zwl_trial@163.com |
| Pengpeng Xu | Contact | +862164370045 | 610707 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200020 | China |
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| Four Courses of R-CHOP Plus Four Courses of Rituximab | Drug | 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) |
|
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.
| Baseline up to data cut-off (up to approximately 2 years) |
| 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 | Up to 30 days after completion of study treatment |
| 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 | Up to 30 days after completion of study treatment |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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