Chidamide With R-CHOP Regimen for DLBCL Patients
Chidamide With R-CHOP Regimen for DLBCL Patients
It's a prospective, single arm, open label phase II clinical trial, in which the safety and
 efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have
 received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed
 positive results.

 abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide,
 etoposide, vincristine and prednisone.

 PR: partial remission; MRD:minimal residual disease;
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;