Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

October 30, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2028

Conditions
AMLIDH1 MutationTreatment
Interventions
DRUG

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"

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER

NCT06611839 - Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML | Biotech Hunter | Biotech Hunter