RecruitingPhase 1NCT05546580

Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study

Sponsor

Oryzon Genomics S.A.

Enrollment

50 participants

Start Date

Nov 14, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia, in Relapse

Summary

Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R/R AML.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two drugs — iadademstat and gilteritinib — in people with a type of blood cancer called acute myeloid leukemia (AML) that has come back or stopped responding to treatment, and specifically carries a genetic mutation called FLT3. **You may be eligible if...** - You have been diagnosed with AML and have the FLT3 mutation (ITD, TKD D835/I836) - Your leukemia has relapsed or is refractory (not responding) after prior treatment - You are in generally good health (ECOG 0–2) - Your liver and kidney function are normal - You are able to swallow pills **You may NOT be eligible if...** - You do not have the FLT3 mutation - You have had more than two relapses - You have active infection or serious heart problems - You are pregnant or breastfeeding - Your bone marrow or organ function is significantly impaired 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

DRUGIadademstat

iadademstat oral solution

DRUGGilteritinib Oral Tablet

120 mg Gilteritinib

Locations(13)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

The John Hopkins University School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Rutgers, The State University

Piscataway, New Jersey, United States

Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, United States

West Virginia University

Morgantown, West Virginia, United States

Froedtert Hospital & The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05546580

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