Clinical Trial

Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes

Active, Not Recruiting Phase 1/2
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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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-03-13; most recent amendment 2026-03-11.
Status change: Recruiting → Active, Not Recruiting 2025-12-03
Status change: Not Yet Recruiting → Recruiting 2024-04-18
Trial Details
NCT Number NCT05782127
Lead Sponsor Groupe Francophone des Myelodysplasies
Collaborators: Bristol-Myers Squibb, AbbVie
Conditions Untreated Myelodysplastic Syndrome
Enrollment 36 participants
Start Date 2023-12-06
Primary Completion 2025-12-01 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-11