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

Sponsor
German CLL Study Group
Study ID
NCT06792994
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jan 27, 2025
Start date
Apr 2, 2026
Status verified
Apr 2026
Primary completion
Aug 1, 2030
Completion
Aug 1, 2030

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

Overall Survival [ Time Frame: Each patient will be followed until death or end of study, whatever occurs first, i.e. 60 months from start nof enrolment. ]

Central Contacts

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