European CML Blast Crisis Register
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- Overall survival
研究概览
简要总结
Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe
详细描述
Since the advent of treatment with tyrosine kinase inhibitors (TKI), the incidence of blast crises has significantly decreased. Nevertheless, about 5% of patients diagnosed with chronic myeloid leukemia (CML) will evolve into a blast phase at some point during the course of their disease. Furthermore, despite the advances made in CML treatment, outcome of patients with blast crises are still dismal. Due to the rarity of this condition clinical trials are challenging, and collaboration between researchers both at national and international level is needed to collect a meaningful number of data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age >18 years
- •Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:
- •Blasts 20% or more of peripheral blood white cells or bone marrow cells or
- •Extramedullary blast proliferation or
- •Large foci or clusters of blasts in bone marrow biopsy
排除标准
- •Lack of informed consent
结局指标
主要结局
Overall survival
时间窗: through study completion in 2024
how many patients survive after a blast crisis event
次要结局
- Rate of molecular response to treatment(through study completion in 2024)
- Rate of hematologic response to treatment(through study completion in 2024)
- Rate of blast crises in Europe in the era of TKI treatment(through study completion in 2024)
研究者
Annamaria Brioli
Principal Investigator
University of Jena