A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- Registration Number
- NCT06205290
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Liso-cel Monotherapy Liso-cel - Arm B: Investigator's Choice Idelalisib - Arm A: Liso-cel Monotherapy Fludarabine - Arm A: Liso-cel Monotherapy Cyclophosphamide - Arm B: Investigator's Choice Rituximab - Arm B: Investigator's Choice Bendamustine -
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) per independent review committee (IRC) assessment Up to 5 years from the last participant randomized
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events of Special Interest (AESIs) 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) Up to 5 years from the last participant randomized 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)Duration of Response (DOR) per IRC assessment Up to 5 years from the last participant randomized Duration of Complete Response (DOCR) per IRC assessment Up to 5 years from the last participant randomized Progression post next line of treatment (PFS-2) Up to 5 years from the last participant randomized Number of participants with Adverse Events (AEs) Up to 5 years from the last participant randomized Overall Survival (OS) Up to 5 years from the last participant randomized PFS per investigators' assessment Up to 5 years from the last participant randomized Number of participants with laboratory abnormalities Up to 5 years from the last participant randomized Minimal residual disease (MRD)-negativity rate Up to 5 years from the last participant randomized ORR per investigators' assessment Up to 5 years from the last participant randomized Complete Response Rate (CRR) per IRC assessment Up to 5 years from the last participant randomized Complete response with incomplete bone marrow recovery (CRi) Up to 5 years from the last participant randomized CRR per investigators' assessment Up to 5 years from the last participant randomized Overall Response Rate (ORR) per IRC assessment 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 Up to 5 years from the last participant randomized As assessed by EORTC QLQ-C30
Mean changes from baseline in the following key HRQoL domains: Physical functioning Up to 5 years from the last participant randomized As assessed by EORTC QLQ-C30
Mean changes from baseline in the following key HRQoL domains: Fatigue Up to 5 years from the last participant randomized As assessed by EORTC QLQ-C30
Mean changes from baseline in the following key HRQoL domains: Symptom burden Up to 5 years from the last participant randomized As assessed by EORTC QLQ-CLL17
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) Up to 5 years from the last participant randomized The following domains on the EORTC QLQ-CLL17 will be assessed:
* Symptom burden
* Physical condition/fatigueMean changes from baseline in the following key HRQoL domains: Role functioning Up to 5 years from the last participant randomized As assessed by EORTC QLQ-C30
Mean changes from baseline in the following key HRQoL domains: Cognitive functioning Up to 5 years from the last participant randomized As assessed by EORTC QLQ-C30
Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue Up to 5 years from the last participant randomized As assessed by EORTC QLQ-CLL17
Trial Locations
- Locations (48)
Local Institution - 0068
🇺🇸Morgantown, West Virginia, United States
Local Institution - 0121
🇺🇸New York, New York, United States
Local Institution - 0036
🇫🇷Montpellier, Languedoc-Roussillon, France
Local Institution - 0107
🇪🇸Santander, Cantabria, Spain
Local Institution - 0106
🇪🇸Valencia, Valenciana, Comunitat, Spain
Local Institution - 0104
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0071
🇸🇪Huddinge, Sweden
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Local Institution - 0101
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0083
🇩🇪Kiel, Schleswig-Holstein, Germany
Local Institution - 0113
🇧🇪Yvoir, Namur, Belgium
Local Institution - 0114
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0073
🇳🇴Oslo, Norway
St. Luke's Mountain States Tumor Institute : Boise
🇺🇸Boise, Idaho, United States
Local Institution - 0117
🇳🇱Groningen, Netherlands
Local Institution - 0112
🇧🇪Leuven, Vlaams-Brabant, Belgium
Local Institution - 0094
🇦🇹Salzburg, Austria
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Local Institution - 0093
🇦🇹Wien, Austria
Local Institution - 0122
🇫🇷Rennes, Bretagne, France
Local Institution - 0058
🇺🇸Iowa City, Iowa, United States
Local Institution - 0120
🇺🇸Atlanta, Georgia, United States
Local Institution - 0023
🇺🇸Duarte, California, United States
Local Institution - 0048
🇺🇸Saint Matthews, Kentucky, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Local Institution - 0037
🇫🇷Paris, France
Local Institution - 0034
🇫🇷Toulouse, France
Local Institution - 0038
🇫🇷Lyon, Rhône-Alpes, France
Local Institution - 0035
🇫🇷Clermont-Ferrand, France
Local Institution - 0079
🇩🇪Heidelberg, Germany
Local Institution - 0091
🇮🇹Milan, Milano, Italy
Local Institution - 0084
🇩🇪Dresden, Sachsen, Germany
Local Institution - 0088
🇮🇹Bologna, Italy
Local Institution - 0105
🇪🇸L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Local Institution - 0082
🇩🇪Köln, Germany
Local Institution - 0080
🇩🇪Ulm, Germany
Local Institution - 0108
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0115
🇬🇧London, London, City Of, United Kingdom
Local Institution - 0110
🇬🇧Oxford, United Kingdom
Local Institution - 0111
🇬🇧Leeds, United Kingdom
Local Institution - 0109
🇬🇧London, London, City Of, United Kingdom
Stony Brook University
🇺🇸Stony Brook, New York, United States
University Hospital and UW Health Clinics
🇺🇸Madison, Wisconsin, United States
Local Institution - 0103
🇪🇸Salamanca, Spain
Local Institution - 0081
🇩🇪Leipzig, Sachsen, Germany
St. David's South Austin Medical Center
🇺🇸Austin, Texas, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
🇺🇸Sacramento, California, United States