High Grade Myelodysplastic Syndromes Clinical Trial
Official title:
Concomitant Omacetaxine Mepesuccinate and Azacitidine for Patients With Previously Untreated High Grade Myelodysplastic Syndromes
This study will treat patients with previously untreated high grade myleodysplastic syndromes (MDS) with both omacetaxine mepesuccinate and azacitidine.
This is an open-label, phase I/II study for previously untreated patients with high grade MDS using omacetaxine and azacitidine with a small expansion cohort for relapsed and refractory MDS patients. Phase I features dose escalation, where patients will be assigned to one of three cohorts to receive different doses of omacetaxine with the standard dose and schedule of azacitidine, over a 28 day cycle. Phase II features the maximum tolerated dose from the Phase 1 study. An additional expansion cohort of 10 MDS patients who have failed to respond to or responded and relapsed after at least one line of therapy containing a hypomethylating agent therapy will also be accrued. ;