NCT06788639招募中不适用
Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Post-Marketing Setting
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年2月4日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
The purpose of this study is to characterize the long-term safety of lisocabtagene maraleucel (liso-cel), focusing on patients treated in the chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Participants must have been treated in the post-marketing setting with ≥1 infusion of lisocabtagene maraleucel used for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within the approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA
排除标准
- •Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion
- •Patients treated with non-conforming CAR T-cell product
研究组 & 干预措施
Participants treated with lisocabtagene maraleucel
干预措施: Lisocabtagene maraleucel (Biological)
结局指标
主要结局
Adverse events (AEs)
时间窗: Up to 15 years
次要结局
- Complete remission rate (CRR(Up to 15 years)
- Overall response rate (ORR)(Up to 15 years)
- Progression-free survival (PFS)(Up to 15 years)
- Overall survival (OS)(Up to 15 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical study to investigate the long-term safety and efficacy of human cell line recombinant Factor VIII (human-cl rhFVIII) in previously treated patients with severe haemophilia ASevere haemophilia AHaematological DisordersHereditary factor VIII deficiencyISRCTN90038418Octapharma AG (Switzerland)22
已完成
不适用
A clinical study for evaluating safety of long-term consumption -Non-blind, safety verification study taking 1 times dose of test food "KW-01" in healthy adults.Healthy adultsJPRN-UMIN000025376Kowa Company, Ltd.10
尚未招募
不适用
An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative DisordersNon-Hodgkin Lymphoma, B-cellAcute Lymphoblastic Leukemia ALLNCT06721598National Research Center for Hematology, Russia60
Unknown
早期 1 期
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette SyndromeTourette SyndromeNCT02253498Beijing Pins Medical Co., Ltd20
进行中（未招募）
4 期
Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica Spectrum DisorderNCT06180278Amgen32