Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Phase 2

Not yet recruiting

• Conditions: AML - Acute Myeloid Leukemia
• Interventions: Drug: Gilteritinib (GILT); Drug: Venetoclax (VEN); Drug: Azacitidine (AZA)

• Registration Number: NCT06696183
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Study Start: 2025-04
• Primary Completion: 2029-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4	Venetoclax (VEN)	GILT d8-d28 VEN d1-d14 AZA d1-d7
Cohort 4	Azacitidine (AZA)	GILT d8-d28 VEN d1-d14 AZA d1-d7
Cohort 3	Gilteritinib (GILT)	GILT d1-d28 VEN d1-d14 AZA d1-d7
Cohort 4	Gilteritinib (GILT)	GILT d8-d28 VEN d1-d14 AZA d1-d7
Cohort 3	Venetoclax (VEN)	GILT d1-d28 VEN d1-d14 AZA d1-d7
Cohort 3	Azacitidine (AZA)	GILT d1-d28 VEN d1-d14 AZA d1-d7
Cohort 1	Gilteritinib (GILT)	GILT d1-d28 VEN d1-d7 AZA d1-d7
Cohort 1	Venetoclax (VEN)	GILT d1-d28 VEN d1-d7 AZA d1-d7
Cohort 1	Azacitidine (AZA)	GILT d1-d28 VEN d1-d7 AZA d1-d7
Cohort 2	Gilteritinib (GILT)	GILT d8-d28 VEN d1-d7 AZA d1-d7
Cohort 2	Venetoclax (VEN)	GILT d8-d28 VEN d1-d7 AZA d1-d7
Cohort 2	Azacitidine (AZA)	GILT d8-d28 VEN d1-d7 AZA d1-d7

Primary Outcome Measures

Name	Time	Method
Ratio of dose delivered/dose planned	12 months