RecruitingPhase 1NCT05756777

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

18 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining gilteritinib (which targets an FLT3 mutation) with either ivosidenib (which targets an IDH1 mutation) or enasidenib (which targets an IDH2 mutation) can help people with relapsed or treatment-resistant acute myeloid leukemia (AML) that has specific genetic mutations. **You may be eligible if...** - You are 18 or older - You have been diagnosed with AML that has relapsed (come back) or is refractory (not responding to treatment) - Your AML has a relevant genetic mutation (FLT3, IDH1, or IDH2) that makes you potentially eligible for one of these targeted drugs - You are willing to follow the study visit schedule **You may NOT be eligible if...** - Your AML does not have the genetic mutations targeted by these drugs - Your cancer has not been previously treated - Your overall health does not meet the required criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05756777


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