3 results
Approved WMOSuspended
To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen).
Approved WMOPending
Main Phase:To demonstrate the superiority of medium-dose BDP/FF/GB pMDI compared to high-dose BDP/FF pMDI in terms of the proportion of subjects exhibiting on average NPAL over 26 weeks of treatment in the study sub-population with PAL at screening…
Approved WMOPending
Primary objective:To assess, in an international pediatric study, the efficacy, in terms of event-free survival, of a combination of ATO and ATRA in newly diagnosed SR APL children and adolescents and to explore the safety and efficacy of a…