Retrospective observational study of the conditions of use, safety and efficacy of MYLOTARG® (Gemtuzumab Ozogamicin, GO) in the treatment of patients with newly diagnosed CD33-positive acute myeloid leukaemia (AML). (MYLobs)

Study identification

• EU PAS number:
  EUPAS44551
• Study ID:
  49206
• Official title and acronym:
  Retrospective observational study of the conditions of use, safety and efficacy of MYLOTARG® (Gemtuzumab Ozogamicin, GO) in the treatment of patients with newly diagnosed CD33-positive acute myeloid leukaemia (AML). (MYLobs)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  A multicentre retrospective observational study, with no impact on the treatment of patients. The target population will include previously untreated CD33-positive AML patients having initiated a MYLOTARG® treatment between 01 December 2014 and 31th October 2022. For each patient, monitoring will extend from the initiation date of the MYLOTARG® treatment, to the date of death or the end of data collection (between 01 January 2022 and 30 June 2022 at the latest), the earliest of these 2 dates.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:14/06/2021

Actual:10/11/2021

Study start date

Planned:01/01/2022

Actual:07/04/2022

Date of final study report

Planned:31/03/2023

Actual:19/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

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