Overview

Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

Status:
Completed
Trial end date:
2016-05-09
Target enrollment:
Participant gender:
Summary
Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing. For the Phase I study : Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS. For the phase II study: Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Treatments:
Azacitidine
Idarubicin