RecruitingPhase 1

A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

United States18 participantsStarted 2023-06-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. For patients who received intensive induction chemotherapy they must have persistent AML (defined as overt disease with over 5% myeloblasts) after at least one cycle of intensive induction OR
✓. For patients treated with low intensity therapy, the patient must be refractory to treatment with a single agent hypomethylating agent (HMA) or low dose cytarabine (LDAC) (at least two cycles) or an HMA/LDAC in combination with venetoclax (at least one cycle) or another standard of care therapy (e.g. gemtuzumab ozogamicin, glasdegib/LDAC).

What they're measuring

Determine the maximum tolerated dose (MTD)

Timeframe: 1 year

Adverse events /toxicities

Timeframe: 1 year

Trial details

NCT IDNCT05756777

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Eytan Stein, MD

646-608-3749 steine@mskcc.org

View on ClinicalTrials.gov More Acute Myeloid Leukemia (AML) trials