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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorGerman CLL Study Group

About this trial

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 criteria

Qualifiers

• 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.

Disqualifiers

• 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

Trial design

Treatments tested in this trial

  • Observational

Treatment groups

2,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

German CLL Study Group

Lead sponsor

GELLC (Grupo Español de Leucemia Linfocítica Crónica)

Collaborator

Nordic Lymphoma Group

Collaborator

Polish Adult Leukemia Group

Collaborator

HOVON - Dutch Haemato-Oncology Association

Collaborator