Study: NCT03416179

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: daunorubicin + cytarabine
Description: '7+3' (cytarabine 100 mg/m2, IV for 7 days by continuous infusion and daunorubicin 60 mg/m2 for 3 days).~If a second induction is needed, Investigators may choose either a 5 day cytarabine continuous infusion plus daunorubicin for 2 days ('5+2') or a 7 day cytarabine continuous infusion plus daunorubicin for 3 days ('7+3');

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: daunorubicin + cytarabine
Description: '7+3' (cytarabine 100 mg/m2, IV for 7 days by continuous infusion and daunorubicin 60 mg/m2 for 3 days).~If a second induction is needed, Investigators may choose either a 5 day cytarabine continuous infusion plus daunorubicin for 2 days ('5+2') or a 7 day cytarabine continuous infusion plus daunorubicin for 3 days ('7+3');

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: azacitidine
Description: Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: azacitidine
Description: Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo (PO) given on Day 1 and is to continue up to 2 years post randomization. Following consolidation therapy, placebo will be administered daily for up to 2 years after randomization or until they have MRD negative disease, whichever comes first.~Daily placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: glasdegib
Description: Glasdegib 100 mg PO QD is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment.~Subjects will continue glasdegib until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Consolidation with single agent cytarabine 3 g/m2 IV for adults \<60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: cytarabine
Description: Consolidation with single agent cytarabine 3 g/m2 IV for adults \<60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: HSCT
Description: If required, and done per standard of care post Induction(s).

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: HSCT
Description: If required, and done per standard of care post Induction(s).