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).
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.
Participant has a diagnosis of secondary CNS lymphoma due to systemic disease.
Primary intraocular lymphoma (PIOL)/ Primary vitreoretinal lymphoma (PVRL), isolated cerebrospinal fluid (CSF) disease, or a relapsed or refractory PCNSL.
Any significant medical condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she was to participate in the study based on investigator's judgement.
History of another primary malignancy that has not been in remission for ≥2 years.
Single group
Rituximab
DrugSpecified dose on specified days
Methotrexate
DrugSpecified dose on specified days
Procarbazine
DrugSpecified dose on specified days
Temozolomide
DrugSpecified dose on specified days
Liso-cel
Biological/VaccineSpecified dose on specified days
Fludarabine
DrugSpecified dose on specified days
Cyclophosphamide
DrugSpecified dose on specified days
Calcium folinate
DrugSpecified dose on specified days
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
PFS
Defined as the time from the date of enrollment to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first
Modified Progression-free Survival (mPFS)
Defined as the time from the date of enrollment to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first. Disease relapse or progression prior to liso-cel infusion is considered as an event only if the patient does not achieve complete response (CR) after liso-cel infusion.
Complete Response Rate (CRR)
Defined as proportion of patients achieving CR at any time between liso-cel infusion and the date of first documented disease relapse or progression as assessed by the investigator, initiation of a new antineoplastic therapy to treat Primary Central Nervous System Lymphoma (PCNSL), or end of study, whichever occurs first
Overall Response Rate (ORR)
Defined as proportion of patients achieving CR or Partial Response (PR) at any time between liso-cel infusion and the date of first documented disease relapse or progression as assessed by the investigator, initiation of a new antineoplastic therapy to treat PCNSL, or end of study, whichever occurs first
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