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

Technische Universität Dresden

Status and phase: Enrolling; Phase 2

Conditions: AML - Acute Myeloid Leukemia

Treatments: Drug: Venetoclax (VEN); Drug: Azacitidine (AZA); Drug: Gilteritinib (GILT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06696183

TUD-SEQUNC-081

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 + 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Cohort 1

Experimental group

Description:

GILT d1-d28 VEN d1-d7 AZA d1-d7

Treatment:

Drug: Gilteritinib (GILT)

Drug: Azacitidine (AZA)

Drug: Venetoclax (VEN)

Cohort 2

Experimental group

Description:

GILT d8-d28 VEN d1-d7 AZA d1-d7

Treatment:

Drug: Gilteritinib (GILT)

Drug: Azacitidine (AZA)

Drug: Venetoclax (VEN)

Cohort 3

Experimental group

Description:

GILT d1-d28 VEN d1-d14 AZA d1-d7

Treatment:

Drug: Gilteritinib (GILT)

Drug: Azacitidine (AZA)

Drug: Venetoclax (VEN)

Cohort 4

Experimental group

Description:

GILT d8-d28 VEN d1-d14 AZA d1-d7

Treatment:

Drug: Gilteritinib (GILT)

Drug: Azacitidine (AZA)

Drug: Venetoclax (VEN)