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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05782127 | Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes | PHASE1 | ACTIVE NOT_RECRUITING | 36 | — | — | Dec 6, 2023 | Nov 1, 2028 | Mar 13, 2026 | 25 | France |
Dose-limiting toxicities according to CTCAE (common terminology criteria for adverses events) 5.0 occurring within the first cycle of treatment
Overall response measured after the first cycle of treatment according to modified IWG-MDS (International Working Group-Myelodysplastic Syndromes) 2006
| Arm | Type | Description |
|---|---|---|
| Onureg + Venetoclax | EXPERIMENTAL | Onureg (CC-486, oral azacitidine) will be administered orally at 200 or 300 mg once daily for 7 or 14 consecutive days, beginning on Day 1 of repeated 28-day cycles. Venetoclax will be administered orally at 400 mg once daily for 14 consecutive days on days 1 to 14, beginning on Day 1 of repeated 28-day cycles. Patients will be treated up to 4 cycles and for a maximum of 24 cycles. |
| Name | Type | Description |
|---|---|---|
| Onureg + Venetoclax | DRUG | Combination of Onureg and Venetoclax |
Inclusion Criteria: 1. Subjects must understand and voluntarily sign and date an ICF indicating the investigational nature of the study, approved by an independent EC/IRB, prior to the initiation of any screening or study-specific procedures. 2. Age ≥ 18 years at the date of signing the ICF. 3. Dia...