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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Dose level (-1) 80mg, (1) 120mg, (2) 120mg
Dose level (-1) 250mg, (1) 250mg, (2) 500mg
Dose level (-1) 50mg, (1) 50mg, (2) 100mg
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk-Commack
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau
Uniondale, New York, United States
RECRUITINGDetermine the maximum tolerated dose (MTD)
These are derived based on Dose Limiting Toxicities (DLT) according to BOIN dose escalation methodology.
Time frame: 1 year
Adverse events /toxicities
will be graded using CTCAE 5.0 and described by frequency, duration and severity of treatment-emergent, treatment-related, and serious adverse events.
Time frame: 1 year
Clinical response
The ORR will be estimated by sample proportion with 95% confidence intervals calculated based on exact binomial distribution.
Time frame: 1 year
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