The study is a randomized phase III trial with a 2x2 factorial design with measurable
residual disease and event-free survival as primary endpoints, respectively. Patients are
upfront randomized for the two induction schedules (Gemtuzumab Ozogamicin (GO)-147 versus
GO-1; ratio 1:1) and for Glasdegib or Placebo (double blinded, ratio 1:1) as adjunct to
consolidation therapy and as single agent 6 months maintenance therapy. Chemotherapy backbone
for induction therapy is standard 7+3 with cytarabine 200mg/m continuously day 1 to day 7,
daunorubicin 60mg/m days 1, 2 and 3 and for consolidation therapy intermediate dose
cytarabine (1g/m, bi-daily, days 1,2,3). The trial is designed to gain evidence of
anti-leukemic activity of GO and Glasdegib in older patients with newly diagnosed acute
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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