Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 14
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Objective Response
研究概览
简要总结
Primary Objective:
To evaluate the efficacy of isatuximab.
Secondary Objectives:
- To evaluate the safety profile of isatuximab.
- To evaluate the duration of response (DOR).
- To evaluate progression free survival (PFS) and overall survival (OS).
- To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL.
- To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL.
- To assess minimal residual disease (MRD) and correlate it with clinical outcome.
详细描述
The study duration per participant included a 3-week screening period, an approximately 1 year of treatment period or until disease progression or discontinuation for any other reason, and a follow-up period of at least 30 days after the last investigational medicinal product administration.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Isatuximab
Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
干预措施: Isatuximab SAR650984 (Drug)
Isatuximab
Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
干预措施: dexamethasone (Drug)
Isatuximab
Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
干预措施: acetaminophen (Drug)
Isatuximab
Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
干预措施: ranitidine (Drug)
Isatuximab
Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
干预措施: diphenhydramine (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response
时间窗: Baseline until disease progression or death (maximum duration: 12.1 weeks)
Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC.
次要结局
- Overall Survival (OS)(Baseline until death (maximum duration: 12.1 weeks))
- Number of Participants With Minimal Residual Disease (MRD)(Baseline until death or study cut-off (maximum duration: 12.1 weeks))
- Duration of Response (DOR)(Baseline until disease progression or death (maximum duration: 12.1 weeks))
- Progression Free Survival (PFS)(Baseline until disease progression or death (maximum duration: 12.1 weeks))