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Gilteritinib, Venetoclax, and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation
NCT06561880Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2024
- Primary completion
- Sep 2026
- Countries
- 1
- Sponsor
- Institute of Hematology and Blood Diseases Hospital
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, randomised, open-label trial of gilteritinib, venetoclax and azacitidine in acute myeloid leukemia (AML) (3 arms), sponsored by Institute of Hematology and Blood Diseases Hospital. Primary endpoints: Composite Complete Remission Rate at 3 months, Composite Complete Remission with Negative Minimal Residual Disease by Flow Cytometry at 1 year and 2 more. Started Oct 2024; status: recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Triple Regimen Induction of Arm1
Azacitidine d1-7; Gilteritinib d1-14; Venetoclax d3-14
Triple Regimen Induction of Arm2
Azacitidine d1-7; Gilteritinib d1-14; Venetoclax d3-7
Triple Regimen Induction of Arm3
Azacitidine d1-7; Gilteritinib d1-7; Venetoclax d3-7
03
Who it enrols
Newly diagnosed fit AML patients >= 15 years old with FLT3-TKD or ITD mutations, ECOG 0-2, adequate organ function, and no prior induction chemotherapy or specific exclusionary fusion genes.
04
Endpoints
Primary
Composite Complete Remission Rate
Composite Complete Remission with Negative Minimal Residual Disease by Flow Cytometry
Tolerated Dose of Triple Regimens
Event-Free Survival
Secondary
Composite Complete Remission with Negative Minimal Residual Disease by Next-Generation Sequencing
Overall Survival
Relapse-Free Survival
30-Day Mortality Rate
60-Day Mortality Rate
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