Long-term survival after different first-line treatments for CLL
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
This follow-up will see if people with CLL who received different first-line treatments in GCLLSG trials live longer over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | German CLL Study Group Academic / other |
| Locations | 2 sites (Cologne and 1 other locations) |
| Trial ID | NCT06792994 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational follow-up of patients who received first-line therapy within the GCLLSG CLL13, CLL14, or CLL17 protocols, with overall survival (OS) from treatment start as the primary endpoint. The study collects information on subsequent therapy lines, comorbidities, genetic and serum markers, and other competing factors that might affect long-term survival. Data are gathered at participating centers and from consenting patients to create a pooled, standardized dataset enabling extended follow-up beyond what individual randomized trials can practically achieve. Collaborative sites across Germany and partner European groups contribute long-term outcome data to improve understanding of survival patterns after contemporary first-line CLL treatments.
Who should consider this trial
Good fit: Ideal candidates are patients with CLL who previously received first-line treatment within the GCLLSG CLL13, CLL14, or CLL17 trials and can provide informed consent for long-term follow-up.
Not a fit: Patients who were not treated within one of the specified GCLLSG first-line trials or who cannot provide consent are not eligible and will not benefit directly from this follow-up dataset.
Why it matters
Potential benefit: If successful, the analysis could help clinicians choose first-line approaches and plan subsequent therapy sequences that are associated with longer overall survival.
How similar studies have performed: Previous registry and population-based studies have provided useful but often retrospective and limited-duration insights, while prospective long-term follow-up within a trial cohort like this is less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • 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 Criteria: * • 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
Where this trial is running
Cologne and 1 other locations
- University Hospital Cologne — Cologne, Germany (Recruiting)
- Universitätsklinikum Ulm — Ulm, Germany (Recruiting)
Study contacts
- Study coordinator: Kirsten Fischer, MD
- Email: kirsten.fischer@uk-koeln.de
- Phone: +4922147888220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.