EINE GLOBALE RANDOMISIERTE MULTIZENTRUMSPHASE 3 VERSUCHE ZUM VERGLEICH DER WIRKSAMKEIT UND SICHERHEIT VON JCAR017 ZUM PFLEGESTANDARD BEI ERWACHSENEN SUBJEKTE MIT HOHEM RISIKO, TRANSPLANTIERBAR REZITIEREN ODER REFRAKTÄR AGGRESSIVE B-ZELL-NON-HODGKIN-LYMPHOME (VERWANDELN)
This is a randomized, open-label, parallel-group, multi-center, Phase 3 study to demonstrate the efficacy and safety of JCAR017 (also known as lisocabtagene maraleucel or liso-cel) versus SOC salvage therapies in subjects with aggressive B-cell NHL (defined as diffuse large B-cell lymphoma [DLBCL] not otherwise specified [NOS] (de novo or transformed follicular lymphoma [tFL]), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double-hit lymphoma/ triple-hit lymphoma [DHL/THL]), or follicular lymphoma Grade 3B [FL3B]) who are refractory to front-line immunochemotherapy or have relapsed within 12 months and are eligible for HDCT and HSCT.
