Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)
研究概览
简要总结
Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CML any phase with T315I mutation
- •Ph+ ALL with a T315I mutation
- •Being treated in the PACE trial according to the criteria of this phase II trial
- •Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen.
排除标准
- •Ph negative patients
- •Patients under 18 years
研究组 & 干预措施
Ponatinib (PACE trial)
PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440
干预措施: Ponatinib (Iclusig®) (Drug)
Allogenis stem cell transplantation (EBMT registry)
EBMT : European Group for Blood and Marrow Transplantation
干预措施: allogeneic stem cell transplantation (Procedure)
结局指标
主要结局
Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)
时间窗: From date of inclusion until the date of death, assessed up to 180 months
次要结局
未报告次要终点