Myelodysplastic Syndrome Clinical Trial
Official title:
Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).
Phase I: The purpose of this study was to determine which of the subcutaneous doses of
decitabine administered twice daily for 5 days maximizes genomic demethylation in patients
with MDS
Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of
the study.
Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due
to a change in product development strategy
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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