# A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

Source: https://onco.cc/trials/nct05520567/  
OnCo record `nct05520567` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Gilteritinib, Venetoclax and Azacitidine in acute myeloid leukaemia, run by Astellas Pharma Global Development, Inc., active and no longer recruiting.

## Summary

A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia is a phase 1/2 interventional study registered as NCT05520567 by Astellas Pharma Global Development, Inc., with 70 participants enrolled, started 2023-01-31 and due to reach its primary completion in 2028-07-31. Interventions recorded: Gilteritinib, Venetoclax and Azacitidine.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05520567
- Phase: 1/2
- Setting: A Phase 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients With Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy
- Sponsor: Astellas Pharma Global Development, Inc.
- Enrolled: 70

## Sources

- ClinicalTrials.gov NCT05520567: https://clinicaltrials.gov/study/NCT05520567

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- drugs: [Azacitidine](https://onco.cc/drugs/azacitidine/), [Gilteritinib](https://onco.cc/drugs/gilteritinib/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [Astellas](https://onco.cc/companies/astellas/)

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JSON: https://onco.cc/api/v1/entities/nct05520567.json