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

RECRUITINGPhase 2Sponsored by Technische Universität Dresden
Actively Recruiting
PhasePhase 2
SponsorTechnische Universität Dresden
Started2025-04-25
Est. completion2029-04
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06696183

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

AML - Acute Myeloid LeukemiaCancer

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