The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.
The purpose of this phase III study is to evaluate the clinical benefit of liso-cel for the treatment of r/r FL by comparing it to standard of care therapy in patients with r/r FL, with progression-free survival (PFS) as the primary endpoint. The primary objective is to demonstrate superiority of the Liso-cel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by independent review committee (IRC) based on the Lugano response criteria. Participants randomized to Arm A (Standard of Care) will receive RCHOP, BR, or R2 based on investigator choice and this has to be determined prior to randomization. Participants randomized to Arm B (Liso-cel treatment) will receive a single infusion CAR-positive viable T-cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Progression-free survival (PFS)
Defined as the time from randomization to death due to any cause or progressive disease (PD) per independent review committee (IRC) assessment using the Lugano 2014 Criteria, whichever occurs first
Time frame: Up to 5 years from the last participant randomized
Complete response (CR)
Defined as participants achieving a complete response per IRC assessment using the Lugano 2014 Criteria
Time frame: Up to 5 years from the last participant randomized
Overall survival (OS)
Defined as the time from randomization to death due to any cause
Time frame: Up to approximately 7 years
Overall response (OR)
Defined as participants achieving a response (CR or partial response (PR)) per IRC assessment using the Lugano 2014 Criteria
Time frame: Up to 5 years from the last participant randomized
Duration of response (DOR)
Defined as the time from first response (CR or PR) per IRC assessment using the Lugano 2014 Criteria to PD or death due to any cause, whichever occurs first
Time frame: Up to 5 years from the last participant randomized
Event-free survival (EFS)
Defined as the time from randomization to the first documentation of progressive disease (PD) per IRC assessed using the Lugano 2014 Criteria start of new anti-cancer therapy, or death due to any cause, whichever occurs first
Time frame: Up to 5 years from the last participant randomized
Time to next anti-cancer therapy (TTNLT)
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Defined as time from randomization to start of new anti-cancer therapy or death due to any cause, whichever occurs first
Time frame: Up to 5 years from the last participant randomized
PFS rate
Time frame: Up to 5 years from the last participant randomized
EFS rate
Time frame: Up to 5 years from the last participant randomized
OS rate
Time frame: Up to approximately 7 years
Progression-free survival on the next line of treatment (PFS-2)
Defined as the time from randomization to death from any cause or tumor progression on next line treatment per Investigator assessment, whichever occurs first
Time frame: Up to 5 years from the last participant randomized
Number of participants with adverse events (AEs)
Time frame: Up to 5 years from the last participant randomized
Number of participants with adverse event of special interest (AESIs)
Time frame: Up to 5 years from the last participant randomized
Number of participants with serious adverse events (SAEs)
Time frame: Up to 5 years from the last participant randomized
Number of participants with laboratory abnormalities
Time frame: Up to 5 years from the last participant randomized
Frequency and length of hospitalizations
Time frame: Up to 5 years from the last participant randomized
Number of participants with intensive care unit (ICU) inpatient days
Time frame: Up to 5 years from the last participant randomized
Number of participants with non-ICU inpatient days
Time frame: Up to 5 years from the last participant randomized
Mean change from baseline in key health-related quality of life (HRQoL) domains.
Key HRQoL Domains: Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)
Time frame: Up to 5 years from the last participant randomized
Time to meaningful improvement/deterioration in key HRQoL domains.
Key HRQoL Domains: Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)
Time frame: Up to 5 years from the last participant randomized