Prospective Multicentre Observational Registry Of Treatments And Outcomes In Patients With Chronic Lymphocytic Leukaemia Or Indolent Non Hodgkin's Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)
研究概览
简要总结
The purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle East and North African (MENA) region. This study will also record encountered tumor subtype and stage and the instituted pharmacological treatments, as well as assess the clinical outcomes of treatments.
详细描述
Patients will be followed up to 30 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Informed consent
- •CLL patients or
- •iNHL patients
- •Clinical decision made to initiate or adapt treatment of CLL/iNHL("Need to treat")
排除标准
- •Patient deemed unfit for enrollment by the documented opinion of the investigator
- •Watch and wait patients
- •Richter's transformation
- •Patients otherwise not eligible for (pharmacological) intervention
- •Moribund patients
结局指标
主要结局
Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)
时间窗: Baseline, 1 year and 2 years after baseline (up to 30 months)
Types of combination treatment (including but not limited to R-CHOP \[rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone\] , FCR \[fludarabine, cyclophosphamide, rituximab\], COP \[cyclophosphamide, doxorubicin, prednisone\], BR \[bendamustine, rituximab\], etc.) will be collected in treatment-naïve and relapsed patients. Data to be described as percentage of patients on each regimen.
次要结局
- CLL specific variable: Clinically relevant biomarker status(up to 30 months)
- Safety as assessed by adverse events(up to 30 months)
- CLL specific variable: Histology(up to 30 months)
- Number of subjects in complete remission(up to 30 months)
- Number of subjects in partial remission(up to 30 months)
- Duration of response(up to 30 months)
- Overall survival(up to 30 months)
- iNHL specific variables: Histology(up to 30 months)
- CLL specific variable: Rai/Binet staging systems(up to 30 months)
- iNHL specific variables: Clinically relevant biomarker status(up to 30 months)
- Progression free survival(up to 30 months)
- Disease type and staging(up to 30 months)
- Clinical responses(up to 30 months)
- Health-related quality of life variables(up to 30 months)
- iNHL specific variables: Ann Arbor staging classification(up to 30 months)