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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.

Phase 2RecruitingTechnische Universität DresdenNCT06696183Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: FLT3 mutation

Prior therapy

Max 1 prior line

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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