drugset / Trial / NCT05782127
Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes
Phase 1/2
Active not recruiting
36 enrolled
Groupe Francophone des Myelodysplasies
AbbVie · collabBristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I/II open-label, dose-finding, multi-center study will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with higher-risk myelodysplastic syndromes (HR-MDS) not eligible to transplant.
Timeline
- Start
- 2023-12-06
- Primary completion
- 2025-12-01
- Completion
- 2028-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 200 mg | Oral |
| Subject | Azacitidine | Other / unclassified | 300 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |