Myelodysplastic Syndrome (MDS) Clinical Trial
Official title:
A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
In this phase II study besides evaluating for safety, the primary efficacy parameter is to
evaluate the incidence of patients who have had a response to Trisenox by evidence of
increased blood counts (red, white, or platelets) and/or by decrease or transfusion
dependency. The secondary efficacy parameter is the assessment of the tolerability of the
new dosing schedule.
Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of
0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of
28 weeks.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
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