The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participant must be 18 years or older at the time of signing the informed consent form (ICF). * Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology. * Transplant-ineligible based on physician's assessment and meeting at least one of the following criteria: age ≥65 years or HCT-CI (Hematopoietic Cell Transplantation-specific Comorbidity Index) score ≥3. * Participant must be suitable, per investigator, to receive a high dose methotrexate (HD-MTX) based treatment regimen. * Prior to signing ICF, a…
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
Locations (40)
- University Of ColoradoAurora, Colorado
- Moffitt Cancer CenterTampa, Florida
- Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicago, Illinois
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Washington University School of Medicine in St. LouisSt Louis, Missouri
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey