A Czech Pharmaco-epidemiological Real-World Data Study Focused on CLL Patient Treatment Options and Their Effectiveness
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study will be a secondary use of data, focusing on patients treated with combination therapy Obi-Clb, R-Clb or R-B, in a non-interventional, open label, national, multicenter setting. Retrospective analysis of data coming from registry database CLLEAR (www.leukemia-cell.org )that capture data on clinical and treatment practices in CLL. Data will be retrospectively analyzed.
详细描述
This study will be a secondary use of data, focusing on patients treated with various treatment regimens (including obinutuzumab based regimen) used in the Czech Republic in a non-interventional, open label, national, multicenter setting. Retrospective analysis of data coming from registry database CLLEAR that capture data on clinical and treatment practices in CLL. This study is not a face to face analysis of treatment regimens. The results of this study could be used to compare with the results from other studies.
Analytical population, selection criteria and sample size
All CLL patients diagnosed, treated or followed in seven leading hematology centers in the Czech Republic since 2011 onward are included in the CLLEAR registry; there are no exclusion criteria. These centers include University Hospital (UH) Brno, General Faculty Hospital in Prague, University Hospital Hradec Kralove, University Hospital Olomouc, University Hospital Ostrava, University Hospital Plzen and Oncology Center Novy Jicin.
In this study, all patients treated with Obi-Clb, R-B and R-Clb regimens and included into the CLLEAR database will be analyzed. There no other selection criteria.
It is estimated that 400 patients will be analyzed in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Chronic Lymphocytic Leukemia
- •Patients treated with Bendamustin plus Rituximab, Rituximab plus Chlorambucil or Obinutuzumab plus Chlorambucil regimens as first line of treatment
- •Provision of informed consent for recording of patient data in the CLLEAR registry
排除标准
- •All untreated patients
- •Patients with both Rituximab plus Chlorambucil and Bendamustin plus Rituximab or Obinutuzumab plus Chlorambucil in second or subsequent lines
- •Patients with prednisone alongside analysed regimens in the first line of treatment
- •Patients with RCD (Rituximab, Cyclophosphamide, Dexamethasone) or FCR (Fludarabine, Cyclophosphamide, Rituximab) or other regimen before analysed regimens within the first line of treatment
- •Patients with R-Dex (Rituximab and Dexamethasone) cycles in between R-Clb cycles
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From the treatment administration until the disease progression, death or date of data export (up to 96 months)
PFS is defined as the number of months from the start of treatment with analyzed therapies (Obi-Clb, R-Clb, BR) until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.
Overall response (ORR) rate
时间窗: From the treatment administration up to approximately 2 months after the end of the analyzed treatment
ORR is defined as the proportion of participants with complete remission (CR) or partial remission (PR) out of the total number of participants. Responses were assessed by using National Cancer Institute - Working Group guidelines on CLL.
Partial response (PR) rate
时间窗: From the treatment administration up to approximately 2 months after the end of the analyzed treatment
Partial response (remission) was assessed by using the National Cancer Institute - Working Group guidelines on CLL. For PR definition see Hallek et al. Blood 2008 111:5446-5456; doi: https://doi.org/10.1182/blood-2007-06-093906
Minimal residual disease (MRD) negativity rate
时间窗: From the treatment administration up to 12 months after the end of the analyzed treatment
The patients who achieved a CR and did not have detectable MRD in the bone marrow by four-color flow cytometry (\<0.1% of cells).
Complete response (CR) rate
时间窗: From the treatment administration up to approximately 2 months after the end of the analyzed treatment
Complete response (remission) was assessed by using the National Cancer Institute - Working Group guidelines on CLL. It is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. For CR definition see Hallek et al. Blood 2008 111:5446-5456; doi: https://doi.org/10.1182/blood-2007-06-093906
次要结局
- Frequency of patients with hematologic adverse events, non-hematologic adverse events and infusion-related reactions(From the treatment administration until the end of the analyzed treatment (up to 96 months))
- Frequency of comorbidities occurring before or during the treatment(From the date of birth of patients until the end of the analyzed treatment (up to 96 months))
- Frequency of patients with a decrease in the number of cycles and with an increase in the number of cycles(Treatment administration (6 cycles, it means 6 months))
- Frequency of patients with a hematologic or non-hematologic adverse event or an infusion-related reaction that needed hospitalization(From the treatment administration until the end of the analyzed treatment (up to 96 months))
研究者
Prof. Michael Doubek, M.D., Ph.D
Head of the Czech CLL Study Group
Brno University Hospital