untreated CD20 positive difussed large B cell lymphoma adults
Conditions
Interventions
Group A:CHOP combined with Rituximab regimen (R-CHOP21)
Group B:Biweekly CHOP combined with Rituximab regimen (R-CHOP14)
Group C:Biweekly CHOP regimen (CHOP14)
Sponsors
Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. To be aged from 18 to 70 years; 2. Histological documented untreated CD20(+) diffused large B cell lymphoma; 3. Measurable disease and evaluable lesion; 4. Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease; 5. Normal Haematological, liver and kidney function (Neutrophil count >=1.5*10^9/L, hemoglobin >=100g/L, platelets >=100*10^9/L); 6. ECOG Performance status 0-3, Life expectancy of at least 3 months; 7. Without history of another malignancy; 8. Without any conflict serious systemic disease; 9. Without any accompany treatment (including steroids drugs); 10. Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are silling to participate in the study; 11. Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum beta-hCG pregnancy test at screening.
Exclusion criteria
Exclusion criteria: 1. Patients with prior clinical study within 3 months; 2. Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy metastasis lymphoma; 3. Primary central nervous system lymphoma or primary testis lymphoma; 4. History of allergic reaction to any ectogenic proteins; 5. Prior treatment for lymphoma; 6. History of another malignancy; 7. Neutrophil count =2*institutional upper limit of normal); 10. liver dysfunction not related to lymphoma (transaminase>=3*institutional upper limit of normal,and/or bilirubin >=2.0mg/dl); 11. clinical syndrome of encephalon functional disorder, serious psychiosis; 12. female subject who is pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression rate of disease;laboratory index;vital sign;response rate;Adverse Events;partial response rate;complete response rate;Serious Adverse Event; | — |
Countries
China
Contacts
Public ContactLin Tongyu
Outcome results
None listed