A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma
A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma
To observe the safety, tolerability and clinical effects of Chidamide Combined With Etoposide
 in Relapsed or Refractory NK/T-cell Lymphoma.
This is a prospective, open-label, one-arm, single center clinical trial, aimed to evaluate
 the safety, tolerability, and efficacy of Chidamide Combined With Etoposide in Relapsed or
 Refractory NK/T-cell Lymphoma. A total of 30 patients are planned to be enrolled into the
 study. Patients with diagnosis of Relapsed or Refractory NK/T-cell Lymphoma will be treated
 with Chidamide plus Etoposide capsules. The primary end points are objective responder rate
 (ORR) and a time to response(TTR) and response duration (DOR) and progression free
 survival(PFS) and adverse events.
Inclusion Criteria:

 1.age:10-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3
 months 2 patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or
 fluorescence in situ hybridization (FISH); 3.Refractory or relapse after at least 2 regimen
 4.Once the patient received radiotherapy, need to be more than 3 months away from this
 treatment, and it is a non-primary recurrence; 5.No chemotherapy contraindications:
 hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L,
 ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal
 Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L; 6.At
 least one measurable lesion 7.There are no other serious diseases that conflict with this
 program, and the cardiopulmonary function is normal; 8.Women of childbearing age must have
 a negative urine or blood pregnancy test, and male patients should be contraceptive during
 medication; 9.There is no other antitumor treatment, but bisphosphonate for anti-bone
 metastasis treatment and other symptomatic treatment can be applied.

 10.Can understand the situation of this study and sign the informed consent voluntarily

 Exclusion Criteria:

 1. rejecting providing blood preparation;

 2. allergic to drug in this study or with hemophagocytic syndrome;

 3. rejecting adopting reliable contraceptive method in pregnancy or lactation period;

 4. uncontrolled internal medicine disease(including uncontrolled diabetes,severe
 incompetence cardiac,lung,liver and pancreas）；

 5. with severe infection;

 6. with primary or secondary central nervous system tumor invasion;

 7. with Chemotherap or radiotherapy contraindication;

 8. ever suffered with malignant tumor;

 9. Human immunodeficiency virus (HIV)-positive patients

 10. Drug abuse or long-term alcohol abuse that affects the evaluation of test results;

 11. Have peripheral nervous system disorder or mental disorder;

 12. Those who have no legal capacity or whose research is affected by medical or ethical
 reasons;