Myelodysplastic Syndrome Clinical Trial
Official title:
A Pilot Phase I Dose Finding Safety Study of a Thrombopoietin-receptor Agonist, Eltrombopag, in Patients With Myelodysplastic Syndrome Treated With Azacitidine
Patients with Myelodysplastic Syndromes (MDS) often suffer from low platelet levels which
may lead to bleeding complications. Treatment with cytotoxic agents can decrease the
platelet levels further. Eltrombopag is a relatively new drug that increases the platelet
level in the blood by working directly on the bone marrow. It is available for treatment of
the disease Immunological Thrombocytopenic Purpura (ITP). In this study patients with MDS
and low platelet levels that are treated with the cytotoxic agent Azacitidine will also
receive Eltrombopag. The administration of Eltrombopag to MDS patients treated with
Azacitidine may result in less dose reductions and less treatment delays for Azacitidine and
may reduce the need for thrombocyte transfusions and lower the risk of bleeding
complications.
This is a phase I study, meaning that our major goal is to investigate the safety and
tolerability for Eltrombopag in this patient group. It will also generate a basis for a
phase II-III-study.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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