Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts
Status:
Completed
Trial end date:
2018-10-03
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to compare overall survival (OS) in patients receiving
ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of
patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow
blasts) who have failed azacitidine or decitabine treatment. This patient population has no
available therapy and a short life expectancy (approximately 4 months). The high level of
bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to
delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant
and severe complication, which shortens survival of these MDS patients.