Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03416179 | A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia | PHASE3 | COMPLETED | 730 | — | — | Apr 20, 2018 | Jan 17, 2022 | Apr 21, 2023 | 149 | United States, Australia +20 |
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.
| Arm | Type | Description |
|---|---|---|
| Arm A (Intensive Study) | EXPERIMENTAL | Glasdegib + '7+3' Induction(s) |
| Arm B (Intensive Study) | PLACEBO_COMPARATOR | Placebo + '7+3' Induction(s) |
| Arm A (Non-intensive study) | EXPERIMENTAL | Glasdegib + azacitidine |
| Arm B (Non-intensive study) | PLACEBO_COMPARATOR | Placebo + azacitidine |
| Name | Type | Description |
|---|---|---|
| glasdegib | DRUG | Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization. Following consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first. Daily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy. |
| daunorubicin + cytarabine | DRUG | '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'); |
| azacitidine | DRUG | 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. |
| Placebo | DRUG | 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. |
| cytarabine | DRUG | 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. |
| HSCT | PROCEDURE | If required, and done per standard of care post Induction(s). |
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated): 1. Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those wi...