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

Conditions

AML (Acute Myeloid Leukemia)

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

Inclusion Criteria4

Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of \>=20%, excluding APL
FLT3 mutation at initial diagnosis
Ineligibility of standard induction chemotherapy
Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)

Exclusion Criteria6

R/R AML
Previous treatment for AML (except HU and/or one cycle VEN+AZA according to SOC)
Previous treatment with Gilteritinib
Known active CNS involvement
QTcF \>450 ms or long QT Syndrome at screening
Treatment with concomitant strong CYP3A inducers or St. John's wort