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NCT Number: NCT06696183

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

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

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Key information

Conditions

AML - Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Technische Universität Dresden

Dresden, 01307, Germany

Location status: Recruiting

Location contact

Prof. Dr. Christoph Röllig, MD, MSc

CONTACT

[email protected]

+49 351 458 4190

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gilteritinib (GILT)

Drug

80 mg

Venetoclax (VEN)

Drug

400 mg

Azacitidine (AZA)

Drug

75 mg/m²

Primary outcomes

  1. Ratio of dose delivered/dose planned

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Dr. Christoph Röllig, MD, MSc

CONTACT

[email protected]

+49 351 458 4190

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment

Acronym: SEQUENCE

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Nov 20, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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