Phase III Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed Double-Expressor DLBCL

R-CHOP : rituximab 375 mg/m2 IV, cyclophosphamide 750 mg/m2 IV, doxorubicin 50 mg/m2 IV, vincristine 1.4 mg/m2 IV \[maximum total 2 mg\], and prednisone \[or equivalent\] 100 mg orally as the background therapy for 6 cycles (21 days/cycle).

Tucidinostat ：30 mg was given orally after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle，for 6 cycles. After cycle 6 patients who are evaluated as complete response will receive 24 weeks additional administrations of Tucidinostat on day 1, day 4, day 8, day 11 in a 21-day cycle.

Placebo：30 mg was given orally after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle，for 6 cycles. After cycle 6 patients who are evaluated as complete response will receive 24 weeks additional administrations of placebo on day 1, day 4, day 8, day 11 in a 21-day cycle.