Chidamide Plus R-CHOP in Elderly DLBCL

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-arm, open-label phase II study of Chidamide in combination with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive

• Age 61-75 years

• ECOG 0,1,2

• Life expectancy>6 months

• Informed consented

• IPI>1

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 CNS lymphoma

• LVEF≤50%

• Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN

• Other uncontrollable medical condition that may that may interfere the participation of the study

• Not able to comply to the protocol for mental or other unknown reasons

• Pregnant or lactation

• HIV infection

• 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.