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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04401748 | Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome | PHASE3 | ACTIVE NOT_RECRUITING | 531 | — | — | Sep 10, 2020 | Jul 1, 2027 | May 6, 2026 | 220 | United States, Australia +21 |
OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Venetoclax + Azacitidine (AZA) | EXPERIMENTAL | Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle. |
| Arm 2: Placebo + Azacitidine | ACTIVE_COMPARATOR | Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle. |
| Name | Type | Description |
|---|---|---|
| Venetoclax | DRUG | Tablet: Oral |
| Azacitidine | DRUG | Subcutaneous (SC) or Intravenous (IV) injection |
| Placebo | DRUG | Tablet; Oral |
Inclusion Criteria: * Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of \< 20% bone marrow blasts per marrow biopsy/aspirate at screening. * Participants must meet the following disease activity crit...