Title | Registry of The German CLL Study Group: Long term follow-up of patients with CLL, B-PLL, T-PLL, SLL, T/ NK-LGL, HCL and Richter’s transformation |
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Protocol IDs | NCT02863692 |
Recruitment Status | active |
Contact | Medical Management: Dr. Anna Fink Dr. Anna Fink Berit Falkowski Silke Schott |
Contact for scientific queries | Dr. Anna Fink Dr. Anna Fink |
Design | Non interventional prospective observational survey |
Objectives | - To determine the outcome of patients with CLL, B-PLL, T-PLL, SLL,
T/ NK-LGL,HCL or Richter’s transformation - To establish bio-banking for CLL, B-PLL, T-PLL, SLL, T/ NK-LGL,HCL or Richter’s transformation |
Primary Endpoint | Overall survival (OS) |
Secondary Endpoints | - Progression free survival (PFS) - Response and PFS to second-line and subsequent therapies - Secondary diseases including malignancies, autoimmune complications and infections - Outcome in biological subgroups - Quality of life and treatment compliance |
Target Population | - All patients who have a confirmed diagnosis of CLL, B-PLL, T-PLL, SLL,
T/ NK-LGL, HCL or Richter’s transformation - Age ≥ 18 years |
Treatment | not specified |
No. of patients | not limited |
Time schedule | Start of recruitment: August 2013 End of study: The duration of the study is not limited. Every patient should be followed until death. |
Protocol Version | 04 Apr 2013 Protocol (Version 1.7) 06 Dec 2013 Protocol (Version 3.0) 28 Aug 2014 Protocol (Version 4.1) 21 Jan 2019 Protocol (Version 5.0) |
Sponsor | University of Cologne |
Principal Investigator | Prof. Dr. Michael Hallek, Department I of Internal Medicine, University Hospital of Cologne |
Coordinating Physician | Dr. Christian Maurer, Department I of Internal Medicine, University Hospital of Cologne |
Documents (password protected) |
Protocol and CRF see Download Center |