OncoMatch/Clinical Trials/NCT05756777
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
Is NCT05756777 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Gilteritinib and Ivosidenib for acute myeloid leukemia (aml).
Treatment: Gilteritinib · Ivosidenib · Enasidenib — The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations. The researchers will also look for the highest dose of the combination of gilteritinib with ivosidenib or enasidenib that causes few or mild side effects. When the highest safe dose is found, they will test that dose in new groups of participants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 mutation
Patient has relapsed or refractory AML with dually mutant IDH2/FLT3, IDH1/FLT3 (ITD or TKD), or other FLT3 mutation sensitive to gilteritinib.
Required: IDH2 mutation
Patient has relapsed or refractory AML with dually mutant IDH2/FLT3
Required: IDH1 mutation
Patient has relapsed or refractory AML with dually mutant IDH1/FLT3 (ITD or TKD)
Performance status
ECOG 0–3(Limited self-care)
Lab requirements
Kidney function
creatinine clearance 30 mL/min (Cockcroft-Gault) or serum creatinine < 2.0
Liver function
AST and ALT 3x ULN and serum direct bilirubin 2.0 x ULN; if leukemic organ involvement, serum direct bilirubin 5.0 x ULN
Cardiac function
LVEF 40% by ECHO or MUGA within 28 days prior to start of study treatment; no significant active cardiac disease within 6 months prior (NYHA class III/IV CHF, ACS, ischemic stroke)
adequate renal function, defined as creatine clearance 30mL/min ... adequate hepatic function, defined as AST and ALT 3x ULN and serum direct bilirubin 2.0 x ULN ... LVEF < 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 28 days prior to the start of study treatment. ... significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or ischemic stroke.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth · Middletown, New Jersey
- Memorial Sloan Kettering Bergen · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack · Commack, New York
- Memorial Sloan Kettering Westchester · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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