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

ConditionAML - Acute Myeloid Leukemia

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorTechnische Universität Dresden

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Gilteritinib (GILT)
Drug
80 mg
Venetoclax (VEN)
Drug
400 mg
Azacitidine (AZA)
Drug
75 mg/m²

Treatment groups

60 Participants

are divided into 4 treatment groups

Group A: Cohort 1Experimental treatment 3 interventions

Group B: Cohort 2Experimental treatment 3 interventions

Group C: Cohort 3Experimental treatment 3 interventions

Group D: Cohort 4Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

Ratio of dose delivered/dose planned

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technische Universität Dresden

Lead sponsor

Source ClinicalTrials.gov

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