6 results
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
Safety:* Evaluate the safety of AVXS-101 through incidence of adverse events (AEs) and/or serious adverse events (SAEs)* Evaluate the safety of AVXS-101 based on the change from baseline in clinical laboratory parametersEfficacy objectives will be…
- The primary objective of the Stratum 1A cohort is to establish the maximum tolerated dose of single agent InO when administered in children with CD22-positive relapsed/refractory BCPALL.- The primary objective of the phase 2 cohort is to establish…
The study will be performed in 2 parts, Parts A and B. The purpose of the study is to investigate to what extent BN201 is tolerated. It will also be investigated how quickly and to what extent BN201 is absorbed and eliminated from the body (this is…
Primary Objectives Efficacy: To demonstrate the superiority of InO monotherapy vs ALLR3 induction in paediatric participants between 1 and < 18 years with HR first bone marrow relapse CD22-positive BCP ALL Secondary Objectives:Key Secondary…
The primary objective of ALLTogether is to improve survival and quality of survival in children and young adults with acute lymphoblastic leukaemia