drugset
drugset / Trial / NCT05371093

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

NCT05371093 ↗

Phase 3 Active not recruiting 231 enrolled Kite, A Gilead Company
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Timeline

Start
2022-09-22
Primary completion
2030-10
Completion
2030-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Axicabtagene Ciloleucel Cell therapy 2 cells/kg Intravenous
Subject Axicabtagene Ciloleucel Cell therapy 2 cells Intravenous
Comparator Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Comparator Lenalidomide Other / unclassified 20 mg Oral
Comparator Prednisone Other / unclassified 40 mg/m2 Oral
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications

lymphoma