Relapsed/Refractory Follicular Lymphoma
Conditions
Brief summary
PFS, defined as the time from randomization to disease progression per the International Working Group Lugano Classification {Cheson 2014} as determined per a blinded central assessment, or death due to any cause.
Detailed description
OS, CR rate per Lugano Classification {Cheson 2014} as determined per a blinded central assessment, ORR (CR + PR per Lugano Classification {Cheson 2014}) as determined per a blinded central assessment, DOR, Duration of CR, EFS, TTNT, Incidence of adverse events (AEs) and clinically significant changes in safety laboratory values, Incidence of replication-competent retrovirus (RCR) detection in blood over time, Changes from baseline in the Global Health Status Quality of Life scale and the physical functioning domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) and the Low Grade NonHodgkin Lymphoma-20 (NHL-LG20), Changes from baseline in the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) and visual analogue scale (VAS).
Interventions
DRUGBendamustine 100mg Powder for Concentrate for Solution for Infusion
DRUGMabThera 500 mg concentrate for solution for infusion
DRUGPrednisolone 5 mg Soluble Tablets
Sponsors
Kite Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from randomization to disease progression per the International Working Group Lugano Classification {Cheson 2014} as determined per a blinded central assessment, or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, CR rate per Lugano Classification {Cheson 2014} as determined per a blinded central assessment, ORR (CR + PR per Lugano Classification {Cheson 2014}) as determined per a blinded central assessment, DOR, Duration of CR, EFS, TTNT, Incidence of adverse events (AEs) and clinically significant changes in safety laboratory values, Incidence of replication-competent retrovirus (RCR) detection in blood over time, Changes from baseline in the Global Health Status Quality of Life scale and the physical functioning domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) and the Low Grade NonHodgkin Lymphoma-20 (NHL-LG20), Changes from baseline in the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) and visual analogue scale (VAS). | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed