R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.

Detailed Description
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The study aims to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.

Official Title
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A Multi-center, Prospective, Randomized Phase III Study of the Safety and Efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

Conditions
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Diffuse Large B-cell Lymphoma, Follicular Lymphoma Grade 3B

Intervention / Treatment
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* Drug: R-CEOP-70
* Drug: R-CEOP-90
* Drug: R-CHOP-50


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed de novo diffuse large B-cell lymphoma or follicular lymphoma grade 3B Age>=16 y.o.,<=80 y.o. ECOG < 3 No past history of malignancy Radiologically measurable disease, CT imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm. Life expectancy>6 months Informed consented Exclusion Criteria: Chemotherapy before Bone marrow transplantation before History of malignancy Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease Primary cutaneous, CNS, mediastinal DLBCL LVEF≤50% Other uncontrollable medical condition that may that may interfere the participation of the study Lab at enrollment(unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<80*10^9/L Hemoglobulin<100g/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation Active liver or biliary disease If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled. HIV infection

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: R-CHOP-50<br>R-CHOP-50 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 50mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles. | Drug: R-CHOP-50<br> <br> |
| Experimental: R-CEOP-70<br>R-CEOP-70 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 70mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles. | Drug: R-CEOP-70<br> <br> |
| Experimental: R-CEOP-90<br>R-CEOP-90 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 90mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles. | Drug: R-CEOP-90<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2 year | 
| Response rate | 21 days as one cycle | Every 4 cycles during treatment and then every 3 months for 2 years | 
| Safety as assessed using the CTCAE | 21 days as one cycle | Days 1 of each course and then every 3 months for 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diffuse large B-cell lymphoma, follicular lymphoma grade 3B