Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated With Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC)
研究概览
简要总结
Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
详细描述
The investigators of the study propose a card of data collection, validated by the scientific council of the group FILO.
The data to be collected are entered on an e-CRF made available to the investigators on a secure site.
The main data collected are as follows
- anonymized demographic data
- Clinical and Biological Data of CLL at Diagnosis
- Previous treatments of LLC and CAI
- clinical and laboratory data at the time of initiation of BCRi treatment
- response to treatment with BCRi
- tolerance to BCRi treatment
- Progression under treatment with BCRi
- Recent news
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
- •Patient with CLL
- •Active autoimmune cytopenia
- •Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia.
排除标准
- •Other lymphoid hemopathy B
- •Absence of documentation of the autoimmunity of cytopenia
研究组 & 干预措施
active CLL treated with ibrutinib or idelalisib for CAI
Patient with CLL Active autoimmune cytopenia Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia.
The progressive nature of contemporary CAI LLC is not a criterion of exclusion.
干预措施: ibrutinib ou idelalisib (Drug)
结局指标
主要结局
Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC)
时间窗: 1 year
Regarding autoimmune cytopenias, the responses to treatments were defined as such: Complete answer * hemoglobin level\> 120 g/l without transfusion * AND platelet count\> 100 G/l * AND reticulocytes \<100 G/l * AND normal LDH level Partial answer * hemoglobin \<120 g/l but with a gain of 2 g/l, without transfusion * OR hemoglobin\> 120 g/l with reticulocytes\> 100 G/l and or high LDH * OR hemoglobin\> 120 g/l with reticulocytes and / or LDH levels not available * AND OR platelet count between 50 and 100 G/l
次要结局
- Efficacy of B-cell receptor inhibitors on the Chronic lymphocytic leukemia (CLL)(1 year)
- Progression Free Survival (PFS) of the autoimmune cytopenia(1 year)
- PFS of the Chronic lymphocytic leukemia(1 year)
- Event Free Survival (EFS)(1 year)
- Time to next treatment (TTNT)(1 year)
- Toxicity profile(1 year)
- Overall survival(1 year)