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Active, not recruiting

NCT Number: NCT04159779

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Athens Gennimatas /ID# 212917, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to Month 36

    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

  2. Complete Response (CR)

    Time frame: Up to Month 36

    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

  3. 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.

  4. Nodule Partial Response (nPR) Rate

    Time frame: Up to Month 36

    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

  5. Partial Response (PR) Rate

    Time frame: Up to Month 36

    Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).

  6. 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.

  7. 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).

  8. Overall Survival (OS)

    Time frame: Up to Month 36

    Defined as the time from first venetoclax intake to death from any cause.

  9. Treatment Duration

    Time frame: Up to Month 36

    Overall treatment duration of venetoclax.

  10. 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).

  11. 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.

  12. 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.

  13. Percentage of Participants with Dose Modifications

    Time frame: Up to Month 36

    Dose modifications include interruptions during ramp-up and maintenance phase.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Clinical Outcomes of Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2019
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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