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

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

Timeline

Start

2010-12-30

Primary completion

2011-06

Completion

2016-05-09

Drugs

Indications