Effect and safety of gemtuzumab ozogamicin for the treatment of patients with acute myeloid leukaemia: a systematic review protocol

INTRODUCTION: Acute myeloid leukaemia (AML) is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells or platelets. Gemtuzumab ozogamicin (GO) holds promise as a new agent that also could be efficacious in newly diagnosed AML with acceptable toxicity. This paper describes the design of a protocol to conduct a systematic review of published studies assessing GO for the treatment of AML.

METHOD AND ANALYSIS: We will conduct a systematic review of randomised controlled trials that investigate the effect and safety of GO for the treatment of patients with AML. We will search for any eligible articles from selected electronic databases. We will follow the Preferred Reporting Items for Systematic reviews and Meta-Analysis for study selection and reporting. We will use The Cochrane Handbook for Systematic Reviews of Interventions and Meta-Analysis as guidance to select eligible studies. All data will be extracted using a standardised data extraction form.

ETHICS AND DISSEMINATION: There was no patient involved in this study, therefore no ethical consideration is needed. The findings of this study will be disseminated in a peer-reviewed journal and any relevant conference presentation.

PROSPERO REGISTRATION NUMBER: CRD42019123286.