study of chidamide as a single-agent treatment for patients with relapse or refractory b-nhl

Conditions: Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Summary: this is a prospective phase ii clinical trial to observe the efficacy and safety of chidamide as a single-agent treatment in patients with relapsed or refractory b-cell non-hodgkin's lymphoma (nhl).

patients with relapsed /refractory aggressive b cell lymphoma usually have a poor prognosis. these patients cannot be treated successfully or tolered with the conventional chemotherapy. epigenetic changes in b-cell lymphoma. thus, epigenetic agents may offer potential improvment of clinical outcomes. chidamide is a new type of oral histone deacetylase inhibitor. our exploratory research found that chidamide was effect in some relapsed /refractory b cell lymphoma patients . thus, we will evaluate the efficacy and safety of chidamide in the patients with aggressive relapsed refractory b cell lymphoma failed from second line chemotherapy.

Eligibility criteria:
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 (dlbcl), mantle cell lymphoma (mcl), transformed indolent lymphoma (tl), and other subtypes that investigators consider to be appropriate to be enrolled; 2. patients achieved cr or pr in previous cytotoxic chemotherapy, and relapsed later than 6 months after remission; 3. patients with dlbcl, fl grade3, malt, lpl and sll received at least two chemotherapy regimens, and patients with fl grade1-2 received at least three chemotherapy regimens; 4. at least one measurable lesion with a longest diameter \>1.5cm or a short axis \>1.0cm; 5. age18-75 years; 6. ecog performance status 0-2; 7. life expectancy no less than 3 months; 8. functions within 7 days prior to enrollment: blood routine test: hb ≥ 80g/l, absolute neutrophil count ≥1.5 × 109/l, platelet ≥60 × 109/l; total bilirubin ≤ 1.5 times of normal maximum, alt/ast≤ 2.5 times of normal maximum, for patients with liver metastasis alt/ast≤ 5 times of normal maximum; serum creatinin≤1.5 times of normal maximum or ccr≥ 60ml/min; 9. lvef ≥ 50% by echocardiography; 10. contraception during and 4 weeks after the study for patients at child bearing age; 11. patients have signed the informed consent form. exclusion criteria: 1. patients received chidamide treatment within 6 months prior to enrollment; 2. patients with burkitt lymphoma, b-lymphoblastic lymphoma, central nervous system lymphoma and hiv-associated lymphoma; 3. patients with a "currently active" second malignancy; 4. patients not recovered from non-hematologic toxicities within 4 weeks prior to enrollment due to chemotherapy, radiation and immunotherapy; 5. patients receiving or received corticosteroids within 2 weeks prior to enrollment; 6. patients with cumulative life time dose of doxorubicin \> 450mg/m2; 7. patients who have been treated with any investigational drug within 4 weeks prior to enrollment; 8. women during pregnancy or lactation; 9. patients with active infection, medical conditions, or mental disorders; 10. patients with active infection of hbv, hcv or hiv; 11. congestive heart failure (nyha grade iii/iv), myocardial infarction within 6 months, qtc elongation with clinical significance (≥480ms), hypertension bp≥150/100 mmhg and symptomatic coronary heart disease that require treatment; 12. patients with drug abuse, long term alcoholism that may impact the results of the trial; 13. non-appropriate patients for the trial according to the judgment of the investigators.