NCT07015242招募中2 期
The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company40 个研究点 分布在 3 个国家目标入组 65 人开始时间: 2025年11月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 40
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Liso-cel Administration
Experimental
干预措施: Methotrexate (Drug)
Liso-cel Administration
Experimental
干预措施: Procarbazine (Drug)
Liso-cel Administration
Experimental
干预措施: Cyclophosphamide (Drug)
Liso-cel Administration
Experimental
干预措施: Rituximab (Drug)
Liso-cel Administration
Experimental
干预措施: Temozolomide (Drug)
Liso-cel Administration
Experimental
干预措施: Calcium folinate (Drug)
Liso-cel Administration
Experimental
干预措施: Fludarabine (Drug)
Liso-cel Administration
Experimental
干预措施: Liso-cel (Biological)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 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
次要结局
- Number of participants with adverse events (AEs)(Up to end of study (approximately 2 years))
- Number of participants with serious adverse events (SAEs)(Up to end of study (approximately 2 years))
- Number of participants with adverse events of special interest (AESIs)(Up to end of study (approximately 2 years))
- Number of participants with laboratory abnormalities(Up to end of study (approximately 2 years))
- Neurocognitive performance (Trial Making Test - Parts A and B)(Up to end of study (approximately 2 years))
- Neurocognitive performance (Montreal Cognitive Assessment (MoCA))(Up to end of study (approximately 2 years))
- Health-related quality of life (HRQoL)(Up to end of study (approximately 2 years))
- PFS(12 months after date of enrollment)
- Modified Progression-free Survival (mPFS)(12 months after date of enrollment)
- Complete Response Rate (CRR)(Up to end of study (approximately 2 years))
- Overall Response Rate (ORR)(Up to end of study (approximately 2 years))
- Duration of Response (DoR)(12 months after liso-cel infusion)
- Event-free Survival (EFS)(12 months after date of enrollment)
- Overall Survival (OS)(12 months after date of enrollment)
研究者
研究点 (40)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)Type 2 Diabetes Mellitus (T2DM)NCT06660173Amgen409
终止
1 期
A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 DiabetesType 2 Diabetes MellitusNCT02020616Eli Lilly and Company60
已完成
1 期
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite AllergyPerennial Allergic RhinoconjunctivitisAllergic AsthmaNCT00652223Cytos Biotechnology AG21
已完成
3 期
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)Crohn's DiseaseNCT00805766Tanabe Pharma Corporation39
招募中
4 期
Clinical study to evaluate the efficacy of a surgical procedure (Selective Laser Trabeculoplasty) in glaucoma patients in Indian population.CTRI/2022/07/044032Carl Zeiss India Bangalore Pvt Ltd