Combining Gilteritinib with Venetoclax and Azacitidine for AML Patients with FLT3 Mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the optimal tolerable and effective dose of Gilteritinib when used alongside standard treatments, Venetoclax and Azacitidine, for patients diagnosed with Acute Myeloid Leukemia (AML) who have FLT3 mutations and are not eligible for intensive chemotherapy. The study focuses on newly diagnosed AML patients with a minimum bone marrow blast count of 20%. Participants will have received only one cycle of the approved combination of Venetoclax and Azacitidine prior to enrollment. The goal is to improve treatment outcomes for this specific patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Technische Universität Dresden
  Dresden, Germany Recruiting

Study contacts

• Study coordinator: Prof. Dr. Christoph Röllig, MD, MSc
• Email: sequence@ukdd.de
• Phone: +49 351 458 4190

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.