Actively Recruiting
A Prospective Observational Trial to Assess Treatment Sequences and Factors That Impact Overall Survival in Patients With Chronic Lymphocytic Leukemia (CLL) Treated Within First-line Studies of the GCLLSG
Led by German CLL Study Group · Updated on 2026-04-30
2000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
G
German CLL Study Group
Lead Sponsor
G
GELLC (Grupo Español de Leucemia Linfocítica Crónica)
Collaborating Sponsor
AI-Summary
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 Richter's 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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily sign and date an informed consent approved by an ethics committee or institutional review board
- Documented diagnosis of CLL at time of inclusion in a first-line study of the GCLLSG (development of Richter's transformation is allowed)
- First-line treatment administered within CLL13, CLL14, or CLL17 first-line studies of the GCLLSG
- Subsequent therapy lines documented during first-line study participation or consented to be documented in this observational trial
- Subjects willing and able to comply with study procedures
You will not qualify if you...
- Patients without participation in one of the first-line studies of the GCLLSG (CLL13, CLL14, CLL17)
- Subjects with legal incapacity
- Subjects institutionalized by regulatory or court order
- Subjects dependent on the sponsor or investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months from start of enrolment
Participants who received first-line treatment in previous clinical trials are observed to collect data on survival, efficacy, quality of life, and safety as part of routine patient care.
Visits occur as part of routine clinical care, including at least annual blood sample collection
Trial Site Locations
Total: 2 locations
1
University Hospital Cologne
Cologne, Germany, 50924
Actively Recruiting
2
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
Research Team
K
Kirsten Fischer, MD
A
Aline Zey, Dipl.Biol.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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