Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06696183

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

Led by Technische Universität Dresden · Updated on 2025-05-29

60

Participants Needed

1

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed AML with at least 20% bone marrow blast count, excluding acute promyelocytic leukemia (APL)
  • Presence of FLT3 mutation at initial diagnosis
  • Ineligible for standard intensive induction chemotherapy
  • Completed one cycle of Venetoclax plus Azacitidine prior to study enrollment
Not Eligible

You will not qualify if you...

  • Relapsed or refractory AML
  • Previous treatments for AML except hydroxyurea or one cycle of Venetoclax plus Azacitidine
  • Prior treatment with Gilteritinib
  • Known active central nervous system involvement
  • QTcF interval greater than 450 ms or long QT Syndrome at screening
  • Use of strong CYP3A inducers or St. John's wort during treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Technische Universität Dresden

Dresden, Germany, 01307

Actively Recruiting

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Research Team

P

Prof. Dr. Christoph Röllig, MD, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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