The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients
Summary
The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).
Arms & interventions
- DrugRituximab
Specified dose on specified days
- DrugMethotrexate
Specified dose on specified days
- DrugProcarbazine
Specified dose on specified days
- DrugTemozolomide
Specified dose on specified days
- BiologicalLiso-cel
Specified dose on specified days
- DrugFludarabine
Specified dose on specified days
- DrugCyclophosphamide
Specified dose on specified days
- DrugCalcium folinate
Specified dose on specified days
Outcome measures
Primary
Progression-free Survival (PFS)
Defined as the time from the date of liso-cel infusion to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first
Time frame: 12 months after liso-cel infusion
Secondary
PFS
Time frame: 12 months after date of enrollment
Modified Progression-free Survival (mPFS)
Time frame: 12 months after date of enrollment
Complete Response Rate (CRR)
Time frame: Up to end of study (approximately 2 years)
Overall Response Rate (ORR)
Time frame: Up to end of study (approximately 2 years)
Duration of Response (DoR)
Time frame: 12 months after liso-cel infusion
Event-free Survival (EFS)
Time frame: 12 months after date of enrollment
Overall Survival (OS)
Time frame: 12 months after date of enrollment
Number of participants with adverse events (AEs)
Time frame: Up to end of study (approximately 2 years)
Number of participants with serious adverse events (SAEs)
Time frame: Up to end of study (approximately 2 years)
Number of participants with adverse events of special interest (AESIs)
Time frame: Up to end of study (approximately 2 years)
Number of participants with laboratory abnormalities
Time frame: Up to end of study (approximately 2 years)
Health-related quality of life (HRQoL)
Time frame: Up to end of study (approximately 2 years)
Health-related quality of life (HRQoL)
Time frame: Up to end of study (approximately 2 years)
Neurocognitive performance (Trial Making Test - Parts A and B)
Time frame: Up to end of study (approximately 2 years)
Neurocognitive performance (Montreal Cognitive Assessment (MoCA))
Time frame: Up to end of study (approximately 2 years)
Eligibility criteria
Study locations (14)
University Of Colorado
Aurora, Colorado, 80045
Moffitt Cancer Center
Tampa, Florida, 33612-9416
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110-1010
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43202-2224
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
Fred Hutchinson Cancer Center
Seattle, Washington, 98109