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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

ConditionChronic Lymphocytic Leukemia
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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    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

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Patienst with CLL who received at least firstline treatment within a clinical trial1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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