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RAvVA: Azacitidine vs Azacitidine + Vorinostat in AML/MDS
NCT01617226Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2012
- Primary completion
- Mar 2016
- Countries
- 1
- Sponsor
- University of Birmingham
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules
- Drugs
- vorinostat
- Conditions
- acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)
01
Overview
Phase 2, randomised, open-label trial of vorinostat in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), sponsored by University of Birmingham. Primary endpoint: Overall Response Rate at 6 months. Started Sep 2012; status: completed.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Adults with AML or high-risk MDS ineligible for intensive chemotherapy, including newly diagnosed, relapsed, or refractory disease.
04
Endpoints
Primary
Overall Response Rate
05
Results
Not all primary endpoints met
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