Chidamide With R-CHOP Regimen for DLBCL Patients

• Chidamide + R-CHOP regimen (Drug), also known as HBI-8000: Patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1;CTX 750mg/m2, ivgtt,d2;EPI 70mg/m2, ivgtt,d2;VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2,PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18;one cycle every 21 days;

Primary outcomes

• complete remission rate [every 3 months until 30 months after the last patient's enrollment]: complete remission rate after treated by Chidamide+ R-CHOP regimen

Secondary outcomes

• progression free survival [from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment]: from date of inclusion to date of progression, relapse, or death from any cause
• overall survival [30 months after the last patient's enrollment]: from the date of inclusion to date of death, irrespective of cause
• adverse events [from the date of first cycle of treatment to 30 months after last patient's enrollment]: any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

1. Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
2. Age between 18 to 75 years old;
3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
5. Life expectancy no less than 6 months
6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
7. IPI mark>1.

Exclusion Criteria:

1. History of autologous stem cell transplantation;
2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
4. Lymphoma originated in the central nervous system;
5. Left ventricular ejection fraction ≦50％
6. Abnormal lab results in enrollment:

   1. Neutrophil count: <1.5*109/L；
   2. Platelet count <75*109/L；
   3. AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level;
   4. serum creatinine >1.5 times the upper limit of normal level;
7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
8. Patients with mental illnesses or other diseases that might not comply with the trial plan;
9. Women during pregnancy or lactation;
10. HIV positive patients;
11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;