OncoMatch/Clinical Trials/NCT06696183
Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Is NCT06696183 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Gilteritinib (GILT) and Venetoclax (VEN) for aml - acute myeloid leukemia.
Treatment: Gilteritinib (GILT) · Venetoclax (VEN) · Azacitidine (AZA) — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 mutation
Prior therapy
Must have received: Venetoclax + Azacitidine (venetoclax, azacitidine) — pre-treatment (one cycle only)
Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)
Cannot have received: Gilteritinib (gilteritinib)
Previous treatment with Gilteritinib
Cannot have received: any AML therapy except hydroxyurea and/or one cycle VEN+AZA
Exception: hydroxyurea and/or one cycle VEN+AZA according to SOC
Previous treatment for AML (except HU and/or one cycle VEN+AZA according to SOC)
Lab requirements
Blood counts
minimum BM blast count of >=20%
Cardiac function
QTcF >450 ms or long QT Syndrome at screening [excluded]
minimum BM blast count of >=20%; QTcF >450 ms or long QT Syndrome at screening [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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