Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma

A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma

This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.

Inclusion Criteria:

• Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)
• Age ≧16 years, ≦75 years
• ECOG (Eastern Cooperative Oncology Group) =0,1,2
• No previous history of malignancy
• Radiologically measurable disease
• Life expectancy>6 months
• Informed consented

Exclusion Criteria:

• Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy

• Lab at enrollment(unless caused by lymphoma)

  • Neutrophile<1.5*10^9/L
  • Platelet<75*10^9/L
  • Hemoglobulin<90g/L
  • ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) >2*ULN,AKP(alkaline phosphatase) or bilirubin >1.5*ULN (upper limit of normal )
  • Creatinine>1.5*ULN

• Other uncontrollable medical condition that may that may interfere the participation of the study

  • Not able to comply to the protocol for mental or other unknown reasons

• Pregnant or lactation

• HIV infection