The CAROLYN Trial: Lisocabtagene Maraleucelas 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

Detailed criteria

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

Drug
Rituximab
Specified dose on specified days
Drug
Methotrexate
Specified dose on specified days
Drug
Procarbazine
Specified dose on specified days
Drug
Temozolomide
Specified dose on specified days
Biological
Liso-cel
Specified dose on specified days
Drug
Fludarabine
Specified dose on specified days
Drug
Cyclophosphamide
Specified dose on specified days

Locations (82)

Local Institution - 307
Stanford, California
Local Institution - 0305
Aurora, Colorado
Local Institution - 305
Aurora, Colorado
Local Institution - 308
Tampa, Florida
Moffitt Cancer Center
Tampa, Florida
Local Institution - 0311
Chicago, Illinois