29
Participants
Start Date
October 30, 2025
Primary Completion Date
October 1, 2026
Study Completion Date
October 1, 2028
Ivosidenib, Venetoclax, Azacitidine
"phase I: Induction therapy:Ivosidenib 、Venetoclax、Azacitidine~Dose climbing stage: adopt the 3 + 3 design principle, and the dose level 0,-1and 1 are set as follows~dose level 0: Ivosidenib 500mg d1-28 Venetoclax 100mg d-3,200mg d-2,400mg d-1,800mg d1-14 Azacitidine 75mg/m2/d, d1-7~dose level -1:Ivosidenib 500mg d1-28 Venetoclax 100mg d-3,200mg d-2,400mg d-1, 600mg d1-14 Azacitidine 75mg/m2/d, d1-5~dose level 1:Ivosidenib 500mg d1-28 Venetoclax 100mg d-3,200mg d-2,400mg d-1 800mg d1-21 Azacitidine 75mg/m2/d, d1-7~Consolidation therapy intermediate-dose cytarabine regimen : 3 courses~If IDH1 mutant residual disease was positive before consolidation chemotherapy, Ivosidenib was added;~Maintenance treatment:~Azacitidine、Venetoclax 、Ivosidenib: 6 courses~phase II: dose based on phase I results"
Institute of Hematology & Blood Diseases Hospital, China
OTHER