Study identification

EU PAS number

EUPAS1000000773

Study ID

1000000773

Official title and acronym

DARWIN EU® - Acute myeloid leukaemia: incidence, patient characteristics, treatments, and survival in the period 2015–2024

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
Germany
Netherlands
Norway
Spain

Study description

Acute myeloid leukaemia (AML) is an aggressive haematological malignancy characterised by the uncontrolled proliferation of myeloid precursors. It primarily affects older adults but is also diagnosed in children.
Despite advances in diagnostics and treatment, survival remains poor, especially among elderly patients.
Diagnosis relies on blast counts and genetic markers, with evolving classifications emphasising molecular features. Standard treatment includes induction chemotherapy and, in eligible patients, allogeneic stem cell transplant. Although novel targeted therapies show promise, further evidence is needed to support their safety.
This study aims to generate real-world evidence on AML incidence, patient characteristics, treatment patterns, and survival, utilising routinely collected healthcare data, to inform both clinical and regulatory decision-making.
This will be the basis for further work on dedicated algorithms from source data to improve data quality and availability in AML.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Anton Barchuk

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable