Myelodysplastic Syndromes (MDS) Clinical Trial
Official title:
A Single Arm Pilot Study of Azacitidine in Myelodysplastic Syndrome / Acute Myeloid Leukaemia, With Eltrombopag Support for Thrombocytopenia.
Myelodysplastic Syndrome (MDS) is a disease of the bone marrow characterized by
anemia,neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet
counts). MDS patients with thrombocytopenia who fail standard therapies require regular
platelet transfusions which are expensive and inconvenient, and are a risk for further
serious bleeding complications. The new treatment of MDS using azacitidine has shown to
increase the survival rate of MDS patients including to improve platelet production over
time. However,in the early cycles of treatment with azacitidine,the low platelet counts tend
to exacerbate before they provide any clinical benefit.
Eltrombopag is a drug designed to activate the thrombopoietin receptor. Eltrombopag has been
able to increase platelet counts in healthy Thrombocytopenia Purpura (ITP), a disease where
patients destroy their own platelets very rapidly and thus develop thrombocytopenia.
Eltrombopag is administered orally and is Therapeutic Goods Administration (TGA) approved
for the treatment of thrombocytopenia in patients with chronic ITP who failed to respond to
standard treatment.
This study is a single arm pilot study to evaluate the safety and tolerability of
Eltrombopag in the treatment of low platelet counts in adult subjects with MDS treated using
azacitidine This study also incorporates a correlative laboratory component designed to
determined the mechanism of action of 5-azacitidine +/- Eltrombopag and to determine a
baseline profile which may predict those most responsive. These studies will incorporate
gene methylation and expression, and immunoprofiling.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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