An Analysis of Historical Data on Hematological Remission and Survival Among Adult Patients With Relapsed / Refractory B-Precursor Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 2,373
- 试验地点
- 1
- 主要终点
- hematological complete remission
研究概览
简要总结
A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.
详细描述
A retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory B-precursor acute lymphoblastic leukemia. Data are aggregated across multiple countries and study sites in the EU and US
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia
- •age 15 or older at time of de novo (initial) diagnosis of acute lymphoblastic leukemia
- •initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later
- •No CNS involvement at relapse
- •No isolated extramedullary relapse
- •Other inclusion criteria may apply
排除标准
- 未提供
结局指标
主要结局
hematological complete remission
时间窗: Approx 1 year
To estimate the proportion of patients in hematological complete remission (CR) for R/R Philadelphia chromosome negative (Ph-) B-precursor ALL patients following relapse or salvage treatment, excluding patients with a first remission duration of \>12 months in first salvage (ie, patients with late relapse in first salvage)
次要结局
- proportion of patients receiving allogeneic hematological stem cell transplantation(Approx 1 year)
- overall survival(Approx 1 year)
- duration of complete remission(Approx 1 year)