Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Chidamide Combined With CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisone ) in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma

This is a single-arm, open-label phase 2study of Chidamide in combination with CHOP in the treatment of subjects with untreated angioimmunoblastic T cell lymphoma.

This open-label, single arm study will evaluate the efficacy and safety of chidamide in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy in previously untreated subjects with angioimmunoblastic T cell lymphoma. Subjects will receive 6 cycles of Chidamide 20mg, day 1,4,8,11, orally (PO) every 21 days, in addition to 6 cycles of CHOP chemotherapy IV every 21 days.

Inclusion Criteria:

1. Pathologically confirmed angioimmunoblastic T cell lymphoma
2. Treatment naive
3. Age > 18 years
4. Must has measurable lesion in CT or PET-CT prior to treatment
5. ECOG 0,1,2
6. Informed consented

Exclusion Criteria:

1. Has accepted Chemotherapy before
2. Has accepted autologous Stem cell transplantation before
3. History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
4. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
5. Primary CNS lymphoma
6. LVEF≤50%
7. Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<75*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN
8. Other uncontrollable medical condition that may that may interfere the participation of the study
9. Not able to comply to the protocol for mental or other unknown reasons
10. Pregnant or lactation
11. HIV infection
12. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.