Study treatment and procedures
toxicity, death, ’
DISEASE PROGRESSION, ADVERSE EVENTS, DISEASE, REMISSION, RESIDUAL DISEASE
Patients in the intensive study received glasdegib 100 mg once daily or placebo starting on Day 1 and continuing for up to 2 years or until treatment failure, hematologic relapse, disease progression, unacceptable toxicity, measurable residual disease (MRD)-negative post-consolidation and/or hematopoietic stem cell transplantation (HSCT), consent withdrawal, or death. ‘7 + 3’ induction therapy consisted of intravenous cytarabine 100 mg/mPatients in the non-intensive study received glasdegib 100 mg once daily or placebo, starting on Day 1, plus subcutaneous or intravenous azacitidine 75 mg/mIn both studies, patients proceeding to HSCT interrupted study therapy 28 days before the start of the conditioning regimen. Single-agent, blinded glasdegib/placebo therapy could be resumed 30–60 days post-HSCT assuming absolute neutrophil count engraftment, no ongoing grade ≥2 graft-versus-host disease, and no ongoing serious adverse events (AEs).For the intensive study, disease assessments were performed after the completion of the first induction chemotherapy, at the end of induction upon at least partial hematologic recovery, at the end of the consolidation period, and before and after HSCT. In addition, patients in remission received disease assessments annually or when relapse was suspected. For the non-intensive study, disease assessments were performed when CR was suspected or after Cycle 6 (whichever was earlier), pre-HSCT, annually for patients in remission, and whenever progressive disease was suspected.