Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Recruiting
Phase 2
Interventional Study
AML - Acute Myeloid Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Technische Universität Dresden · Other
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About This Trial
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
Trial Locations
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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 + Azacit…
Contacts