2024-511594-30-00招募中3 期
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 143
- 试验地点
- 27
- 主要终点
- PFS, defined as the time from randomization to disease progression per the International Working Group Lugano Classification {Cheson 2014} as determined per a blinded central assessment, or death due to any cause.
研究概览
简要总结
To determine if axicabtagene ciloleucel is superior to standard of care therapy (SOCT), as measured by progression-free survival (PFS) per a blinded independent radiologic review committee (hereafter referred to as blinded central assessment) in subjects with r/r FL
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
- •Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
- •Clinical indication for treatment.
- •At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
- •Adequate renal, hepatic, pulmonary, and cardiac function
排除标准
- •Presence of large B cell lymphoma or transformed FL
- •History or presence of a clincially significant central nervous system (CNS) disorder.
- •History of autoimmune disease
- •Known history or CNS lymphoma involvement
- •Cardiac lymphoma involvement
- •History of clinically significant cardiac disease 6 months before randomization
- •Neuropathy greater than grade 2
- •Females who are pregnant or breastfeeding
- •Individuals of both genders who are not willing to practice birth control
- •Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
- •Small lymphocytic lymphoma
- •Lymphoplasmacytic lymphoma
- •Full-thickness involvement of the gastric wall by lymphoma
- •FL Grade 3b
- •Prior CD19-targeted therapy
- •Prior CAR therapy or other genetically modified T-cell therapy
- •Uncontrolled fungal, bacterial, viral, or other infection
- •Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
结局指标
主要结局
PFS, defined as the time from randomization to disease progression per the International Working Group Lugano Classification {Cheson 2014} as determined per a blinded central assessment, or death due to any cause.
PFS, defined as the time from randomization to disease progression per the International Working Group Lugano Classification {Cheson 2014} as determined per a blinded central assessment, or death due to any cause.
次要结局
- OS
- CR rate per Lugano Classification {Cheson 2014} as determined per a blinded central assessment
- ORR (CR + PR per Lugano Classification {Cheson 2014}) as determined per a blinded central assessment
- DOR
- Duration of CR
- EFS
- TTNT
- Incidence of adverse events (AEs) and clinically significant changes in safety laboratory values
- Incidence of replication-competent retrovirus (RCR) detection in blood over time
- Changes from baseline in the Global Health Status Quality of Life scale and the physical functioning domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) and the Low Grade NonHodgkin Lymphoma-20 (NHL-LG20)
- Changes from baseline in the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) and visual analogue scale (VAS).
研究者
EU CT Support
Scientific
Kite Pharma Inc.
研究点 (27)
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