41
Participants
Start Date
July 1, 2022
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
ACHOP
"1. Phase I Azacitidine D-2\~D1, starting from dose level 1. Based on the BOIN design described above, if no DLT is identified in level 1, the dose will be escalated stepwise to levels 2, 3, and then 4.~ Azacitidine combined with CHOP regimen every 3 weeks as below:~ * Level 1 - Azacitidine 50mg/m2 D-2, -1, 1~ * Level 2 - Azacitidine 75mg/m2 D-2, -1, 1~ * Level 3 - Azacitidine 100mg/m2 D-2, -1, 1~ * Level 4 - Azacitidine 125mg/m2 D-2, -1, 1~ Azacitidine at each level will be combined with the corresponding CHOP regimen as follows:~ * Cyclophosphamide 750mg/m2 d1~ * Doxorubicin 50 mg/m2 d1~ * Vincristine 1.4 mg/m2 (Max: 2 mg) d1~ * Prednisolone 100mg PO d1-5~2. Phase II~ * Azacitidine determined dose daily for D-2, -1, 1~ * CHOP (Cyclophosphamide 750mg/m2 d1, Doxorubicin 50 mg/m2 d1, Vincristine 1.4 mg/m2 (Max: 2 mg) d1, Prednisolone 100mg PO d1-5), 6 cycles in total"
RECRUITING
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea, Seoul
Won Seog Kim
OTHER