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

NCT06792994 | Recruiting

• 1 other identifier: CLL2000
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Long-term observation, CLL

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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.

  Each patient will be followed until death or end of study, whatever occurs first, i.e. 60 months from start nof enrolment.

Study Arms (1)

Patienst with CLL who received at least firstline treatment within a clinical trial

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

Other: Observational

Interventions

Observational OTHER

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

Patienst with CLL who received at least firstline treatment within a clinical trial

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This observational trial will enrol patients who received first-line treatment in either CLL13, CLL14, or CLL17 trial. On ground of feasibility the sample size is estimat-ed at 1800-2000 patients in total. No formal sample size calculation has been performed.. The study population is defined as all patients who received first-line treatment in CLL13, CLL14, or CLL17 trial, regardless of whether they received any subse-quent lines of CLL therapy or not.

You may qualify if:

• Subjects must voluntarily sign and date an informed consent, ap-proved by an independent ethics committee (IEC)/institutional review board (IRB)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• German CLL Study Group: lead
• GELLC (Grupo Español de Leucemia Linfocítica Crónica): collaborator
• Nordic Lymphoma Group: collaborator
• Polish Adult Leukemia Group: collaborator
• HOVON - Dutch Haemato-Oncology Association: collaborator

Study Sites (2)

University Hospital Cologne

Cologne, 50924, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Optional: Additional blood samples taken no more than once a year as part of routine care (no additional venous puncture is required).

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• BArbara F. Eichhorst, MD

  Uniklinik Köln

  STUDY CHAIR

Central Study Contacts

Kirsten Fischer, MD

CONTACT

+4922147888220; kirsten.fischer@uk-koeln.de

Aline Zey, Dipl.Biol.

CONTACT

+4922147888220; aline.zey@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: April 2, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

DE (2)