The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Progression Free Survival (PFS) per independent review committee (IRC) assessment
Time frame: Up to 5 years from the last participant randomized
Overall Survival (OS)
Time frame: Up to 5 years from the last participant randomized
Complete Response Rate (CRR) per IRC assessment
Time frame: Up to 5 years from the last participant randomized
CRR per investigators' assessment
Time frame: Up to 5 years from the last participant randomized
Complete response with incomplete bone marrow recovery (CRi)
Time frame: Up to 5 years from the last participant randomized
Minimal residual disease (MRD)-negativity rate
Time frame: Up to 5 years from the last participant randomized
Overall Response Rate (ORR) per IRC assessment
Time frame: Up to 5 years from the last participant randomized
ORR per investigators' assessment
Time frame: Up to 5 years from the last participant randomized
Duration of Response (DOR) per IRC assessment
Time frame: Up to 5 years from the last participant randomized
Duration of Complete Response (DOCR) per IRC assessment
Time frame: Up to 5 years from the last participant randomized
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Local Institution - 0023
Duarte, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
Local Institution - 0120
Atlanta, Georgia, United States
St. Luke's Mountain States Tumor Institute : Boise
Boise, Idaho, United States
Local Institution - 0058
Iowa City, Iowa, United States
Local Institution - 0048
Saint Matthews, Kentucky, United States
Local Institution - 0101
Minneapolis, Minnesota, United States
Local Institution - 0121
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
...and 38 more locations
PFS per investigators' assessment
Time frame: Up to 5 years from the last participant randomized
Progression post next line of treatment (PFS-2)
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 Events of Special Interest (AESIs)
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
Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)
The following domains on the EORTC QLQ-C30 will be assessed: * Fatigue * Physical functioning * Role functioning * Cognitive functioning * Global health status/quality of life (GHS/QoL)
Time frame: Up to 5 years from the last participant randomized
Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Quality of Life Module Chronic Lymphocytic Leukemia 17 (EORTC QLQ-CLL17)
The following domains on the EORTC QLQ-CLL17 will be assessed: * Symptom burden * Physical condition/fatigue
Time frame: Up to 5 years from the last participant randomized
Mean changes from baseline in the following key health-related quality of life (HRQoL) domains: GHS/QoL
As assessed by EORTC QLQ-C30
Time frame: Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Fatigue
As assessed by EORTC QLQ-C30
Time frame: Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Physical functioning
As assessed by EORTC QLQ-C30
Time frame: Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Role functioning
As assessed by EORTC QLQ-C30
Time frame: Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Cognitive functioning
As assessed by EORTC QLQ-C30
Time frame: Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Symptom burden
As assessed by EORTC QLQ-CLL17
Time frame: Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue
As assessed by EORTC QLQ-CLL17
Time frame: Up to 5 years from the last participant randomized