A Phase 1b Multi-center Study of the FLT3 Inhibitor Gilteritinib in Combination With the IDH1 Inhibitor Ivosidenib or the IDH2 Inhibitor Enasidenib for Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-occurring FLT3/IDH1 or FLT3/IDH2 Mutations
Summary
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.
Arms & interventions
- DrugGilteritinib
Dose level (-1) 80mg, (1) 120mg, (2) 120mg
- DrugIvosidenib
Dose level (-1) 250mg, (1) 250mg, (2) 500mg
- DrugEnasidenib
Dose level (-1) 50mg, (1) 50mg, (2) 100mg
Outcome measures
Primary
Determine 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
Secondary
Clinical response
Time frame: 1 year
Eligibility criteria
Study locations (7)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk-Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553