Study identification

EU PAS number

EUPAS49268

Study ID

50630

Official title and acronym

GO-First: Real-world treatment patterns and effectiveness outcomes associated with gemtuzumab ozogamicin in first-line Acute Myeloid Leukaemia

DARWIN EU® study

No

Study countries

Austria
Belgium
Germany

Study description

Gemtuzumab ozogamicin (GO) Mylotarg® is an antibody-drug conjugate used for the treatment of acute myeloid leukemia (AML) patients with myeloid cells that express the CD33 receptor. The ALFA 0701 was a multi-centre Phase 3 trial investigating the efficacy of GO combined with chemotherapy or chemotherapy alone as a treatment for first-line CD33+ AML. There is limited real-world knowledge of GO in combination with chemotherapy in a population similar to the trial, using GO similar to the trial. The 'GO-First' study will retrospectively identify real-world patients from Austria, Belgium and Germany who have been treated with GO in a first-line AML setting and their associated treatment patterns and outcomes.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Medical University of Vienna
Austria
First published:
26/02/2024
Institution Educational Institution Hospital/Clinic/Other health care facility
University of Cologne Germany, UZ Leuven Belgium, AZ Sint Jan Brugge Belgium, UZ Brussel Belgium, Medical University of Vienna Austria, Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT) Austria

Contact details

Russell-Smith Alexander

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable