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

Launched by TECHNISCHE UNIVERSITÄT DRESDEN · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for patients with Acute Myeloid Leukemia (AML) who have a specific genetic change called a FLT3 mutation. The researchers want to find out the best dose of a drug called Gilteritinib when it's used together with two other medications, Venetoclax and Azacitidine. This study is focused on patients who cannot receive standard intensive chemotherapy due to various health reasons.

To be eligible for the trial, participants must have recently been diagnosed with AML, have a FLT3 mutation, and cannot undergo standard chemotherapy. They should also have received one cycle of Venetoclax and Azacitidine before joining the study. Participants will be monitored for how well they tolerate the treatment and how effective it is. The trial is not yet recruiting, meaning that it hasn't started enrolling patients yet, but it's an important step in exploring new options for those who need them.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • 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)
• Main Exclusion Criteria:
• • 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