A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma
Cyclophosphamide: Specified dose on specified days
Calcium folinate: Specified dose on specified days
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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, anti-cancer therapy for the treatment of PCNSL must be limited to HD-MTX based standard of care regimens with a minimum of 4 and maximum of 6 doses of MTX. Corticosteroids used as part of standard-of-care management for PCNSL symptom control are permitted prior to ICF signature but must be discontinued at the time of ICF signature. For medical conditions other than PCNSL, non-therapeutic corticosteroids use may be permitted on study.
* Prior to enrollment, participant's disease must be sensitive to prior high-dose methotrexate-based (HD-MTX) regimens, as demonstrated by a complete response (CR, no remaining signs of PCNSL) or a partial response (PR, signs of PNCSL mostly gone) per Investigator's assessment, based on the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* No prior experimental treatments for PCNSL.
* Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention.
Exclusion Criteria
* 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.
a. Exceptions include certain adequately treated non-invasive malignancies, localized prostate cancer treated with curative intent, and completely resected Stage 1 solid tumors with a low risk of recurrence.
* Prior treatment with CAR T-cell or any other gene therapy product that utilizes human genome-editing technology.
* History of or active human immunodeficiency virus (HIV).
* Active hepatitis B or active hepatitis C.
* Active autoimmune disease requiring immunosuppressive therapy.
* History of prior allogeneic transplant, or solid organ transplant requiring immunosuppressive therapy.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
Progression-free Survival (PFS) — 12 months after liso-cel infusion 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
Trial sites (40)
Facility
City
Region
Status
University Of Colorado
Aurora
Colorado
Recruiting
Moffitt Cancer Center
Tampa
Florida
Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago
Illinois
Recruiting
Dana-Farber Cancer Institute
Boston
Massachusetts
Recruiting
Washington University School of Medicine in St. Louis
St Louis
Missouri
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo
New York
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus
Ohio
Recruiting
University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
Sarah Cannon Research Institute Oncology Partners
Nashville
Tennessee
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
Fred Hutchinson Cancer Center
Seattle
Washington
Recruiting
Local Institution - 0111
Nice
Alpes-Maritimes
Not Yet Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes
Loire-Atlantique
Recruiting
Local Institution - 0103
Pierre-Bénite
Rhône
Not Yet Recruiting
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon
France
Recruiting
Chru De Lille - Hopital Claude Huriez
Lille
France
Recruiting
Local Institution - 0112
Marseille
France
Not Yet Recruiting
CHU Montpellier
Montpellier
France
Recruiting
Local Institution - 0114
Paris
France
Not Yet Recruiting
Local Institution - 0102
Paris
France
Not Yet Recruiting
Local Institution - 0108
Pessac
France
Not Yet Recruiting
CHU de Rennes - Hopital de Pontchaillou
Rennes
France
Recruiting
Centre Henri Becquerel
Rouen
France
Recruiting
Local Institution - 0110
Saint-Cloud
France
Not Yet Recruiting
Local Institution - 0115
Strasbourg
France
Not Yet Recruiting
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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