Observational Study on Treatment Effects and Long-Term Survival in Adults with Chronic Lymphocytic Leukemia Treated in First-Line German Trials

What this Trial Is About

This research aims to investigate long-term overall survival OS in adults with Chronic Lymphocytic Leukemia CLL who received first-line treatments in previous clinical trials conducted by the German CLL Study Group. The study focuses on comparing survival outcomes based on different first-line therapies from the CLL13, CLL14, or CLL17 trials and understanding how subsequent treatments and patient factors influence survival. The trial also evaluates quality of life and the occurrence of second primary malignancies and Richters transformations in this patient population. Participants previously treated in the specified first-line trials will be enrolled in this observational study where data collection occurs as part of routine care. Retrospective documentation will capture treatment and health information from the end of their first-line trial participation to the start of this study. Moving forward, survival, treatment efficacy, safety events, and quality of life will be prospectively monitored. Blood samples may be collected once a year during routine visits to explore biomarkers without requiring extra procedures. During the study, participants will be followed for up to 60 months from enrollment or until death. Researchers will collect clinical data, patient health status, treatment history, and outcomes, including survival time and quality of life measures. Safety monitoring will include tracking new cancers and causes of death. This comprehensive follow-up aims to provide insights into factors affecting long-term outcomes in CLL patients treated within first-line clinical trials.

A Prospective Observational Trial to Assess Treatment Sequences and Factors That Impact Overall Sur-vival in Patients With Chronic Lymphocytic Leukaemia (CLL) Treated Within First-line Studies of the GCLLSG