A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

Phase 3 Active not recruiting 109 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.

Evaluation	Drug	Modality	Dose	Route
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Comparator	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Comparator	Lenalidomide	Other / unclassified	20 mg	—
Comparator	Prednisolone	Other / unclassified	40 mg/m2	Oral
Comparator	Prednisone	Other / unclassified	40 mg/m2	Oral
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Subject	Tisagenlecleucel	Cell therapy	6e+07 cells	Intravenous
Subject	Tisagenlecleucel	Cell therapy	6e+08 cells	Intravenous
Comparator	Vincristine	Small molecule	1.4 unknown	Intravenous
Background	Bendamustine	Small molecule	90 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	250 mg/m2	Intravenous
Background	Fludarabine	Small molecule	25 mg/m2	Intravenous