3 results
Approved WMOCompleted
(1) To generate new clinical efficacy and safety data to support the registration of Insuman Implantable 400 IU/ml,(2) To ensure the continuation of the treatment of the patients already implanted and avoid pump explantation, up to the approval of…
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
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…