Patients initially are randomized into 2 arms: Arm I: R-DA-EPOCH; Arm II: R-CEOP90; Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols.
Patients initially are randomized into 2 arms: Arm I: R-DA-EPOCH; Arm II: R-CEOP90; Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols. The overall purpose of the study is to determine if R-CEOP90 followed by auto-HSCT has similar efficacy compared to that with R-DA-EPOCH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
475
R-DA-EPOCH-21 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy.
R-CEOP90 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
progression-free survival
Time to disease progression is calculated in months from day of enrollment in the study until disease progression, as appropriate
Time frame: Two-year survival
complete response
(physical examination, standard blood tests, including assessment of LDH level, thoracic and abdominal computerized tomography (together with any other anatomic site, as clinically indicated), bone marrow biopsy in case of bone marrow involvement and 18F-fludeoxyglucose positron emission tomography (18FDG-PET) (not mandatory) in case of residual measurable disease at the end of the chemoimmunotherapy)
Time frame: 6 cycles
overall survival
Survival time is calculated in months from day of enrollment in the study until death, as appropriate
Time frame: Two-year survival
Incidence of Treatment-Emergent Adverse Events
Adverse Events (AEs) occurring during the protocol-specified reporting period are documented.
Time frame: During the treatment
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