A Czech Pharmaco-epidemiological Real-World Data Study Focused on CLL Patient Treatment Options and Their Effectiveness (GO-CLLEAR)

NCT03881592 UNKNOWN

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.

Details

Lead sponsor	Brno University Hospital
Status	UNKNOWN
Enrolment	400
Start date	2018-11-01
Completion	2019-09

Conditions

• Chronic Lymphocytic Leukemia

Primary outcomes

• Progression-free survival (PFS) — 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.
• Complete response (CR) rate — 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
• Partial response (PR) rate — 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
• Overall response (ORR) rate — 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.
• Minimal residual disease (MRD) negativity rate — 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).

Countries

Czechia