Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes
The primary endpoint of this study is to estimate morphologic complete remission rate. Estimation of response rate is also a secondary objection.
Myelodysplastic syndrome (MDS) is a hematological disorder characterized by ineffective
hematopoiesis. The only known curative treatment for patients with MDS is allogeneic stem
cell transplantation. However, only a minority of patients are candidates for this
aggressive therapy. DNA hypomethylation agents have been shown to have activity in this
disorder and are postulated to work by reversing this epigenetic mechanism of
gene-silencing. Recently, 5-azacitidine, administered subcutaneously for seven days,
received approval by the FDA for the therapy of MDS based on a randomized trial which
demonstrated a diminished risk of leukemic transformation and improved survival when
compared to best supportive care.
The subcutaneous route of administration can present challenges to implementing this
therapy. In the CALGB studies 8921 and 9221, approximately 23% of patients had significant
injection site pain. Moreover, 35 % of patients had injection site bruising which can be
extensive in thrombocytopenic patients. Due to limitations on drug concentration and
administration volumes for subcutaneous dosing, patients often need to have two or three
injections at separate sites each day to meet target dosing. In addition, the schedule of
administration is inconvenient in an outpatient setting secondary to the need to schedule
administrations over weekends. Therefore, there is great interest in pursuing an abbreviated
intravenous route for administration of the drug.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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