Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Number of participants achieving an Objective Response Rate
研究概览
简要总结
Primary Objective:
Participants achieving an Objective Response Rate
Secondary Objectives:
- Response duration
- Progression Free Survival
- Minimal residual disease
- Safety
- Pharmacokinetics
详细描述
The duration of the study for an individual patient will include:
-
The screening period = up to 4 weeks prior to the first administration of SAR3419.
-
The treatment period:
-
Induction period = 4 to 8 weeks
-
Maintenance = up to a total maintenance treatment of 6 months
-
A safety follow-up period of 42 days after the last dose.
-
Any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first.
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
SAR3419
Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.
干预措施: SAR3419 (Drug)
结局指标
主要结局
Number of participants achieving an Objective Response Rate
时间窗: 4 to 8 weeks
次要结局
- Assessment of PK parameter - area under curve (AUC)(Up to 8 months)
- Assessment of PK parameter - half-life (T1/2)(Up to 8 months)
- Assessment of PK parameter - clearance(Up to 8 months)
- Assessment of PK parameter - volume in steady state (Vss)(Up to 8 months)
- Number of participants with Adverse Events(Up to 1 year)
- Assessment of PK parameter - maximum concentration (Cmax)(Up to 8 months)
- Assessment of minimal residual disease (MRD)(4 to 8 weeks)