Clinical trial · Observational
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
NCT06792994CI-TRIAL-00109855CLL2000recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patienst with CLL who received at least firstline treatment within a clinical trial
- description
- This trial will enroll patients who received first-line treatment in either CLL13, CLL14, or CLL17 trial. On ground of feasibility the sample size of the study is estimated at approximately 1800-2100 patients in total. No formal sample size calculation has been performed
- interventionNames
- Other: Observational
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Each patient will be followed until death or end of study, whatever occurs first, i.e. 60 months from start nof enrolment.
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.