A Study of Clinical Outcomes in Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece

Overview

This study is being done to evaluate the clinical outcomes of Chronic Lymphocytic Leukemia (CLL) participants treated with venetoclax as routine standard of care in Greece. The decision to treat with venetoclax is made by the participant's physician prior to being offered enrollment in this study. The objectives of this study include determining overall response rate, assessing safety information, analyzing patient profiles and disease characteristics and participant quality of life.

Full Title of Study: “Clinical Outcomes of Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2026

Arms, Groups and Cohorts

  • Venetoclax Participants
    • Participants for whom the treating physician has decided to treat with venetoclax before enrollment in this study.

Clinical Trial Outcome Measures

Primary Measures

  • Overall Response Rate (ORR)
    • Time Frame: At Month 12
    • Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines and includes partial response (PR), nodular partial response (nPR), complete response with incomplete bone marrow recovery (CRi), and complete response (CR).

Secondary Measures

  • Overall Response Rate (ORR)
    • Time Frame: Up to Month 36
    • Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Complete Response (CR)
    • Time Frame: Up to Month 36
    • Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate
    • Time Frame: Up to Month 36
    • Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Nodule Partial Response (nPR) Rate
    • Time Frame: Up to Month 36
    • Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Partial Response (PR) Rate
    • Time Frame: Up to Month 36
    • Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
  • Percentage of Participants With Disease Progression or Death
    • Time Frame: Up to Month 36
    • Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
  • Progression Free Survival (PFS)
    • Time Frame: Up to Month 36
    • Defined as the time between the date of first venetoclax intake and the date of the first assessment documenting progression or death (from any cause).
  • Overall Survival (OS)
    • Time Frame: Up to Month 36
    • Defined as the time from first venetoclax intake to death from any cause.
  • Treatment Duration
    • Time Frame: Up to Month 36
    • Overall treatment duration of venetoclax.
  • Time to Progression (TTP)
    • Time Frame: Up to Month 36
    • Defined as the period from first venetoclax intake until objective disease progression (until disease progression or death due to progression, whichever occurs first).
  • Change in Patient Reported Outcomes
    • Time Frame: From Baseline (Week 0) Up to Month 36
    • The 5-Level EuroQol Group Questionnaire (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
  • Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)
    • Time Frame: Up to Month 36
    • Determined by assessment of peripheral blood or bone marrow after treatment.
  • Percentage of Participants with Dose Modifications
    • Time Frame: Up to Month 36
    • Dose modifications include interruptions during ramp-up and maintenance phase.
  • Percentage of Participants with Adverse Drug Reactions (ADR)
    • Time Frame: Up to Month 36
    • ADR is defined as a response to a medicinal product that is noxious and unintended and that a causal relationship between a medicinal product and an adverse event is possible, probable or very likely as assessed by the investigator.
  • Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia
    • Time Frame: Up to Month 36
    • Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia.

Participating in This Clinical Trial

Inclusion Criteria

  • Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria – Eligible to receive venetoclax as per local label – Physician has decided to initiate CLL treatment with venetoclax and the decision to treat is made by the physician in accordance with the local label prior to any decision to approach the participant about the study – Participant has been fully informed verbally and in writing about the study and does not object to their data being processed or subjected to data quality control Exclusion Criteria:

  • Prescribed or treated with venetoclax outside of marketing authorization – Currently participating in, or previously participated within 30 days prior to venetoclax start, in any other interventional clinical trial

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ABBVIE INC., Study Director, AbbVie

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