Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
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/m² continuously day 1 to day 7,
daunorubicin 60mg/m² days 1, 2 and 3 and for consolidation therapy intermediate dose
cytarabine (1g/m², 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
myeloid leukemia.