Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Study of Chidamide as a single-agent treatment for patients with relapse or refractory
 Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of
 relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to
 observe the efficacy and safety of Chidamide as a single-agent treatment in patients with
 relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL).
 Moreover, the aim was to study the correlation of clinical efficacy to mutation of certain
 genes as well.
Inclusion Criteria:

 1. Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
 according to "2016 WHO classification of tumors of haematopoietic and lymphoid
 tissues";

 2. Patients must have received systemic treatment (including chemotherapy or
 Hematopoietic stem cell transplantation), but did not achieve remission or had relapse
 after remission;

 3. At least one measurable lesion;

 4. Age 18-75 years, male or female;

 5. ECOG performance status 0-1;

 6. Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 ×
 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;.

 7. Life expectancy no less than 3 months;

 8. Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks
 before enrollment;

 9. Patients have signed the Informed Consent Form.

 Exclusion Criteria:

 1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive
 measures.

 2. QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular
 tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction
 within 1 year, congestive heart failure, symptomatic coronary heart disease that
 requires treatment;

 3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;

 4. Patients have undergone organ transplantation;

 5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior
 to enrollment.

 6. Patients with active hemorrhage.

 7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or
 cerebral infarction.

 8. Patients with active infection, or with continuous fever within 14 days prior to
 enrollment.

 9. Had major organ surgery within 6 weeks prior to enrollment.

 10. Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5
 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5
 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of
 normal maximum).

 11. Patients with mental disorders or those do not have the ability to consent.

 12. Patients with drug abuse, long term alcoholism that may impact the results of the
 trial.

 13. Patients who have central nervous system involvements;

 14. Non-appropriate patients for the trial according to the judgment of the investigators.