Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide
 combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with
 relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
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 combined with DICE in patients with relapsed or
 refractory B-cell Non-Hodgkin's Lymphoma (NHL).
Inclusion Criteria:

 1. Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification
 of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell
 Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma,
 transformed indolent lymphoma, and other subtypes that investigators consider to be
 appropriate to be enrolled;

 2. Patients must have received at least one systemic treatment (including chemotherapy),
 but did not achieve remission or had relapse after remission;

 3. At least one measurable lesion;

 4. Age18-65 years, male or female; ECOG performance status 0-1;

 5. Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 ×
 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;.

 6. Life expectancy no less than 3 months;

 7. Not received chemotherapy, targeted medicine or stem cell transplantation 4 weeks
 before enrollment;

 8. Patients have signed the Informed Consent Form.

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 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 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. Patients with active infection of HBV, HCV or HIV;

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

 11. 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).

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

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

 14. Patients who have central nervous system involvements;

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

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