NCT07684131招募中不适用
AN OBSERVATORY FOR PATIENTS AGED 18 YEARS AND OVER WITH PHILADELPHIA CHROMOSOME POSITIVE (PH+ OR BCR::ABL1+) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) AND TREATED WITH THE COMBINATION OF BCR::ABL1 INHIBITORS AND CHEMOTHERAPY AND/OR CORTICOSTEROIDS AND/OR A MONOCLONAL ANTIBODY.
Versailles Hospital23 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 23
- 主要终点
- Overall survival by 12 months
研究概览
简要总结
An observatory for patients aged 18 years and over with Philadelphia chromosome positive (Ph+ or BCR::ABL1) acute lymphoblastic leukemia (ALL) and treated with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticosteroids and/or a monoclonal antibody.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Male or female patients ≥ 18 years
- •Philadelphia chromosome or BCR::ABL1 positive acute lymphoblastic leukaemia
- •Treatment with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticotherapy and/or a monoclonal antibody
排除标准
- •Patients deceded and having previously refused data collection
- •Not included in a prospective clinical trial
结局指标
主要结局
Overall survival by 12 months
时间窗: 12 months
次要结局
- Death in complete remission(36 months)
- the molecular response defined by BCR//ABL1/ABL1 ratio in bone marrow and/or peripheral blood(36 months)
- the molecular response defined by IGTR quantification proportion in bone marrow and/or peripheral blood(36 months)
- Event free survival(36 months)
- Relapse free survival(36 months)
- the incidence ofBCR..ABL1 TK mutations(36 months)
- treatment tolerance(36 months)
- Death during induction(2 months)
- overal survival by 36 months(36 months)
- proportion of complete remission(36 months)
研究者
Philippe ROUSSELOT
Professor
Versailles Hospital
研究点 (23)
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