RecruitingPhase 2NCT06696183

Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment


Sponsor

Technische Universität Dresden

Enrollment

60 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Summary

Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — gilteritinib, venetoclax, and azacitidine — for people newly diagnosed with a type of blood cancer called acute myeloid leukemia (AML) who also have a specific gene mutation (FLT3) and cannot tolerate aggressive chemotherapy. **You may be eligible if...** - You have been newly diagnosed with AML with at least 20% abnormal cells in the bone marrow - Your tumor has a FLT3 gene mutation - Doctors have determined you are not a candidate for standard intensive chemotherapy - You have already received one cycle of venetoclax + azacitidine as standard care **You may NOT be eligible if...** - Your AML has returned or stopped responding to prior treatment - You have previously been treated with gilteritinib - You have cancer that has spread to the brain or spinal fluid - You have a heart rhythm condition called long QT syndrome - You are taking certain medications that affect how the body processes drugs (strong CYP3A inducers) 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 (GILT)

80 mg

DRUGVenetoclax (VEN)

400 mg

DRUGAzacitidine (AZA)

75 mg/m²


Locations(1)

Technische Universität Dresden

Dresden, Germany

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NCT06696183