Tests gilteritinib with venetoclax and azacitidine for acute myeloid leukemia with FLT3 mutations
Tests gilteritinib with venetoclax and azacitidine in adults with newly diagnosed acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Key facts
- Where
- Aachen, Augsburg, Chemnitz, Dresden, Duesseldorf, Erlangen, Essen, Frankfurt Am Main, Heidelberg, Leipzig, Munich, Münster, and Wiesbaden, GermanySee the 13 sites
- Phase
- Phase 2
Where in Germany
- Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
- Universitaetsklinikum AugsburgAugsburg, GermanyTaking people
- Klinikum Chemnitz gGmbHChemnitz, GermanyTaking people
- Technische Universität DresdenDresden, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Goethe University FrankfurtFrankfurt Am Main, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaet LeipzigLeipzig, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
- University Hospital MunsterMünster, GermanyTaking people
- Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbHWiesbaden, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Technische Universität Dresden
- Trial code
- NCT06696183EU 2023-507878-41-00
- Record updated
- 29 May 2025
- Original description
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 chemotherapyRead full original descriptionShow less
Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment
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
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.