Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes
Status:
Withdrawn
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and
tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who
achieved a hematological response after 6 cycles of azacitidine. After approval by an
independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an
open label randomized phase II study designed to characterize the efficacy, safety, and
tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher
risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of
azacitidine.