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
German CLL Study Group
2,000 participants
Apr 2, 2026
OBSERVATIONAL
Conditions
Summary
This observational trial is designed to investigate long-term survival with regard to the primary endpoint overall survival (OS) after start of first-line treatment.
Eligibility
Inclusion Criteria5
- Subjects must voluntarily sign and date an informed consent, ap-proved by an independent ethics committee (IEC)/institutional review board (IRB)
- Documented diagnosis of CLL at time point of inclusion in a first-line study of the GCLLSG (development of RT is not an exclusion criterion)
- First-line treatment was administered within one of these first-line studies of the GCLLSG (CLL13, CLL14, or CLL17).
- Subsequent therapy lines were either documented during the participa-tion in a first-line study of the GCLLSG or patient consented to have the subsequent therapy lines documented within this observational trial.
- Subjects are willing and able to comply with procedures required in this protocol.
Exclusion Criteria4
- Patients without participation in one of the first-line studies of the GCLLSG (CLL13, CLL14, CLL17)
- Subjects with legal incapacity
- Subjects who are institutionalized by regulatory or court order
- Subjects who are in dependence to the sponsor or the investigator
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Interventions
The data of this observational trial will be collected as part of routine patient care. Data relating to the time period between the end of participation in the clini-cal first-line trial (CLL13, CLL14, or CLL17) and inclusion in the observational trial will be documented retrospectively at the time point of inclusion in the observa-tional trial. From inclusion in the observational trial, data on survival, long-term efficacy, quality of life, and safety will be collected prospectively
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06792994