2 results
Approved WMOCompleted
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Approved WMOCompleted
PART B (FL phase IIb *PARADIGME*):Primary objective:Randomised section of Part B- To evaluate the efficacy of the *40/15* dose regimen (40 mg lilotomab / 15 MBq/kg Betalutin) compared with *100/20* dose regimen (100 mg/m2 lilotomab/ 20 MBq/kg…