Reduced Chemotherapy in Low Risk DLBCL

Study Overview
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Brief Summary
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This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.

Official Title
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Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma.

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: Cyclophosphamide
* Drug: Epirubicin
* Drug: Vincristine
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21 Age>=14 y.o.,<=75 y.o. IPI=0-1 non-bulky (largest diameter <7.5cm) ECOG =0-1 Life expectancy>6 months Informed consented Exclusion Criteria: Chemotherapy before Stem cell transplantation before History of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease Primary cutaneous, CNS 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 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: 14 Years
Maximum Age: 75 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: 6R-CHOP+2R<br>6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days | Drug: Rituximab<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Epirubicin<br> <br> Drug: Vincristine<br> <br> Drug: Prednisone<br> <br> |
| Experimental: 4R-CHOP+4R<br>4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days | Drug: Rituximab<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Epirubicin<br> <br> Drug: Vincristine<br> <br> Drug: Prednisone<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 | 
| Complete Response rate |  | 21 days after 8 cycles of treatment（each cycle is 21 days） | 
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |  | Each cycle of treatment（each cycle is 21 days）and then every 3 months for 2 years |