Ponatinib Survey: Retrospective Evaluation of CML Patients in the National Compassionate Program According to the 648/96 Decree
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- Number of adverse events
研究概览
简要总结
This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.
详细描述
This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.
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 Ph+ patients in chronic phase
- •18 years old or older
- •Patients have received either Dasatinib or Nilotinib and resulted resistant or not tolerant to the drugs or have developed the T3151 mutation
- •Patients have started Ponatinib at least 12 months before registration
- •Informed consent signed at registration
排除标准
- •CML Ph+ patients in accelerated or blast phase with acute lymphoblastic leukemia
研究组 & 干预措施
CML ph+ patients
Chronic myeloid leukemia patients who are philadelphia positive
干预措施: Ponatinib (Drug)
结局指标
主要结局
Number of adverse events
时间窗: Maximum of 60 months from treatment start
General adverse events and grade 3-4 adverse events according to NCI CTCAE version 4.0
次要结局
- Number of patients with hematological complete response(Maximum of 60 months from treatment start)
- Number of mutations(Maximum of 60 months from treatment start)
- Number of patients in progression free survival(12 months after patient enrollment in the study)
- Total number of patients alive(12 months after patient enrollment in the study)
- Number of days from treatment start till response(Maximum of 60 months from treatment start)
- Number of patients in event free survival(12 months after patient enrollment in the study)
- Number of units of Ponatinib administered per units of time(Maximum of 60 months from treatment start)