About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Rituximab
- Methotrexate
- Procarbazine
- Temozolomide
- Liso-cel
- Fludarabine
- Cyclophosphamide
- Calcium folinate