A Retrospective Analysis of Hematological Relapse Free Survival and Overall Survival in Adult Patients With Philadelphia-Negative B-Precursor Acute Lymphoblastic Leukemia in Complete Hematological Remission With Minimal Residual Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- hematological relapse free survival
研究概览
简要总结
A retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia patients.
详细描述
A retrospective observational study reviewing historical survival data (relapse free survival and overall survival) for adult patients who have philadelphia negative B-precursor acute lymphoblastic leukemia, and are in complete hematological remission with minimal residual disease.
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
- •patients with Philadelphia-negative B-Precursor Acute Lyphmoblastic Leukemia in complete hematological remission defined as less than 5% blasts in bone marrow after at least 3 intensive chemotherapy blocks (i.e. any standard or investigational regimen according to adult protocols as long as 3 age appropriate chemotherapy blocks were given, this also includes relapse treatment
- •detection of minimal residual disease (molecular failure or molecular relapse) at a level of greater than or equal to 10*(-4) by PCR or greater than or equal to 10*(-3) by flow cytometry at a reference lab
- •Age 15 or greater at time of initial diagnosis with acute lymphoblastic leukemia. For patients aged 15-17 treatment according to adult protocols is required
- •Initial diagnosis in the year 2000 or later
- •History of acute lymphoblastic leukemia treatment (including response to first therapy, number of prior relapses) is available
- •Relapse status and disease follow up after timepoint of minimal residual disease detection is available
排除标准
- •Patients with extramedullary disease at timepoint of minimal residual disease detection
- •Use of Blinatumomab within 18 months of minimal residual disease detection
- •Allogeneic hematopoietic stem cell transplantation prior to minimal residual disease detection at the required level
结局指标
主要结局
hematological relapse free survival
时间窗: Approximately 18 months
to estimate the hematological relapse free survival in patients who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first)
次要结局
- overall survival(Approximately 18 months)
- mortality rate(100 days following allogeniec stem cell transplantation)
- hematological relapse free survival(Approximately 18 months)