Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
NCT ID: NCT06696183
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-04-25
2030-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
GILT d1-d28 VEN d1-d7 AZA d1-d7
Gilteritinib (GILT)
80 mg
Venetoclax (VEN)
400 mg
Azacitidine (AZA)
75 mg/m²
Cohort 2
GILT d8-d28 VEN d1-d7 AZA d1-d7
Gilteritinib (GILT)
80 mg
Venetoclax (VEN)
400 mg
Azacitidine (AZA)
75 mg/m²
Cohort 3
GILT d1-d28 VEN d1-d14 AZA d1-d7
Gilteritinib (GILT)
80 mg
Venetoclax (VEN)
400 mg
Azacitidine (AZA)
75 mg/m²
Cohort 4
GILT d8-d28 VEN d1-d14 AZA d1-d7
Gilteritinib (GILT)
80 mg
Venetoclax (VEN)
400 mg
Azacitidine (AZA)
75 mg/m²
Interventions
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Gilteritinib (GILT)
80 mg
Venetoclax (VEN)
400 mg
Azacitidine (AZA)
75 mg/m²
Eligibility Criteria
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Inclusion Criteria
* FLT3 mutation at initial diagnosis
* Ineligibility of standard induction chemotherapy
* Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Responsible Party
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Locations
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Technische Universität Dresden
Dresden, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TUD-SEQUNC-081
Identifier Type: -
Identifier Source: org_study_id
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