Gemtuzumab ozogamicin (GO) monotherapy versus standard supportive care for previously untreated AML in elderly patients who are not eligible for intensive chemotherapy: a randomized phase II/III trial (AML-19) of the EORTC-LG and GIMEMA-ALWP.
Phase of Trial: Phase II/III
Latest Information Update: 01 Sep 2017
At a glance
- Drugs Gemtuzumab ozogamicin (Primary)
- Indications Acute myeloid leukaemia
- Focus Therapeutic Use
- 01 Sep 2017 According to a Pfizer media release, the US FDA approved MYLOTARG (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML. The approval of MYLOTARG was based on several investigator-led clinical trials, including ALFA-0701, AML-19 and MyloFrance-1.
- 25 Jan 2016 Final results of the phase III part of the study published in the Journal of Clinical Oncology
- 08 Dec 2014 Primary endpoint for phase III (Overall survival) has been met according to the abstract presented at the 56th Annual Meeting and Exposition of the American Society of Hematology.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History