A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee
研究概览
简要总结
The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse
- •Relapsed or refractory disease after at least 2 lines of chemotherapy
- •ECOG performance status 0 or 1
- •Absence of significant donor (product)-specific anti-HLA antibodies (DSA)
- •Adequate hematological, renal and liver function
排除标准
- •Active central nervous system involvement by malignancy
- •Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
- •Hypocellular bone marrow for age
研究组 & 干预措施
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
干预措施: ALLO-647 (Biological)
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
干预措施: Fludarabine (Drug)
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
干预措施: Cyclophosphamide (Drug)
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
干预措施: ALLO-501A (Genetic)
Lymphodepletion with fludarabine and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
干预措施: Fludarabine (Drug)
Lymphodepletion with fludarabine and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
干预措施: Cyclophosphamide (Drug)
Lymphodepletion with fludarabine and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
干预措施: ALLO-501A (Genetic)
结局指标
主要结局
Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee
时间窗: Up to 60 months
To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by Independent Review Committee (IRC) in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma). In this study, PFS is defined as the time from randomization to disease progression, or relapse per the Lugano classification criteria (Cheson et al, 2014) as assessed by IRC or death.
次要结局
- Overall-response Rate (ORR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee(Up to 60 months)
- Event-Free-Survival (EFS) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee(Up to 60 months)
- Overall Survival (OS) of a Lymphodepletion Regimen Containing FCA vs FC(Up to 60 months, study completion, or death, whichever occurs earlier. Specifically, OS was followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.)
- Duration of Response (DOR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee(Up to 60 months)
- Duration of Response, Event-Free Survival and Progression-Free Survival of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review(Neither participant was a responder, therefore DOR was not followed. EFS and PFS were followed from first dose of study treatment until disease progression, subsequent anticancer therapy, or death. EFS and PFS were followed for 0.99 to 1.84 months.)
- Depth and Duration of a Lymphodepletion Regimen Containing FCA vs FC(From study treatment to study discontinuation, death, withdrawal of consent, or date of initiation of another anticancer therapy, whichever occurs first, for a maximum of 9 months. Only Day 28 lymphocyte counts are available for both participants.)
- Overall Response Rate of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review(Overall Response Rate was followed until disease progression or subsequent anticancer therapy, whichever occurred earlier. Specifically, ORR was followed for 0.99 to 1.84 months for each participant in the FCA and FC arm, respectively.)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Up to 60 months, study completion, or death, whichever occurs earlier. TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.)
- Incidence of ALLO-501A Related Treatment Emergent Adverse Events(Up to 60 months, study completion, or death, whichever occurs earlier. Related TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.)