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
First line of the email MUST contain NCT # and Site #.
CONTACT
Lead
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
