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Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts

Conditions

Chronic Myelomonocytic Leukemia | MDS | Myelodysplastic Syndromes | RAEB

What is the purpose of this trial?

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.



Participation Guidelines

Age:
18 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Onconova Therapeutics, Inc.
The Leukemia and Lymphoma Society
Dates:
November 2010
Last Updated:
February 3, 2014
Study HIC#:
1108008919

Clinicaltrials.gov ID: NCT01241500