NCT06696183RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- 25 Apr 2025
- Primary completion date
- Apr 2029
- Lead sponsor
- Technische Universität Dresden
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06696183
- EU CT number
- 2023-507878-41-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 25 Apr 2025 to the primary completion date, Apr 2029
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Recruiting |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| University Hospital Munster Coordinator of this site? Confirm its status | Münster | Germany | Recruiting |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.