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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50630
• 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 institution and networks

Institutions

Pfizer

University of Cologne

Medical University of Vienna

Austria

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

Study timelines

Date when funding contract was signed

Planned: 02/01/2023

Study start date

Planned: 16/01/2023

Date of final study report

Planned: 30/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Study protocol

Initial protocol

B1761038 GO-First Protocol 12Oct22 v1.0_FINAL

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

Pfizer study number B1761038