French Observational study on patients’ Characteristics, Utilization and Survival outcomes in Gilteritinib-treated patients (FOCUS)

Study identification

• EU PAS number:
  EUPAS1000000597
• Study ID:
  1000000597
• Official title and acronym:
  French Observational study on patients’ Characteristics, Utilization and Survival outcomes in Gilteritinib-treated patients (FOCUS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Acute myeloid leukemia (AML) is a type of cancer when the bone marrow makes too many abnormal white blood cells. Gilteritinib is an approved treatment for people with AML with the faulty FLT3 gene who haven’t responded to previous treatment, or their cancer came back after previous treatment.
• Study status:
  Planned

Research institutions and networks

Institutions

Astellas Pharma Europe Ltd.

Study timelines

Date when funding contract was signed

Planned: 31/01/2025

Actual: 07/01/2025

Study start date

Planned: 31/05/2025

Data analysis start date

Planned: 30/06/2025

Date of interim report, if expected

Planned: 31/08/2025

Date of final study report

Planned: 31/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe Ltd.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

2215-MA-3585