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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04231851 | CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia | PHASE2 | ACTIVE NOT_RECRUITING | 30 | — | — | Feb 19, 2020 | Jun 30, 2027 | Mar 6, 2026 | 4 | United States |
This is defined as the percentage of subjects with event-free survival (EFS) at 6 months. EFS is defined as the number of months where patients are in a remission state.
| Arm | Type | Description |
|---|---|---|
| CPX-351 and Glasdegib | EXPERIMENTAL | In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28. If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28. In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28. If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year |
| Name | Type | Description |
|---|---|---|
| Glasdegib | DRUG | Given PO |
| CPX-351 | DRUG | Given IV |
Inclusion Criteria: * Previously untreated therapy-related AML or AML with myelodysplastic related changes as described by World Health Organization (WHO) 2016 1. AML arising in MDS (including CMML) or MDS/MPN syndrome 2. AML with MDS-related cytogenetic abnormalities (Appendix A, metaphase FI...