Reduced Chemotherapy in Low Risk DLBCL

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Cyclophosphamide; Epirubicin; Prednisone; Rituximab; Vincristine

Criteria

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