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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06696183

Acronym

SEQUENCE

Enrollment

Registered

2024-11-20

Start date

2025-04-25

Completion date

2030-04-30

Last updated

2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML - Acute Myeloid Leukemia

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

Interventions

DRUGGilteritinib (GILT)

80 mg

DRUGVenetoclax (VEN)

400 mg

DRUGAzacitidine (AZA)

75 mg/m²

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Ratio of dose delivered/dose planned	12 months

Countries

Germany

Contacts

Primary ContactProf. Dr. Christoph Röllig, MD, MSc

sequence@ukdd.de+49 351 458 4190

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026