DCLLSG

Registry of the German CLL Study Group

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
Protocol IDs NCT02863692
Recruitment Status active
Contact Medical Management: Dr. Anna Fink

Dr. Anna Fink
+49 221 478-88198
anna-maria.fink@uk-koeln.de

Project Management: Berit Falkowski

Berit Falkowski
+49 221 478-96581
berit.falkowski@uk-koeln.de

Data Management: Silke Schott

Silke Schott
+49 221 478-42565
silke.schott@uk-koeln.de

Contact for scientific queries Dr. Anna Fink

Dr. Anna Fink
+49 221 478-88198
anna-maria.fink@uk-koeln.de

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