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Tests treatment safety and results for Lymphoma
Official title 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
ClinicalTrials.gov ID: NCT07015242
What this study is testing
What is Rituximab?
Rituximab is an investigational medicine, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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...
- Any significant medical condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she was...
- History of another primary malignancy that has not been in remission for ≥2 years.
- 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).
See the full eligibility 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...
- Prior to ICF 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Nice, Alpes-Maritimes, France
- Nantes, Loire-Atlantique, France
- Pierre-Bénite, Rhône, France
- Dijon, France
- Lille, France
- Marseille, France
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; New Brunswick, New Jersey, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.