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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Lymphocytic Leukemia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Venetoclax Participants<br>Participants for whom the treating physician has decided to treat with venetoclax before enrollment in this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | 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). | At Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 | 
| Complete Response (CR) | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 | 
| Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 | 
| Nodule Partial Response (nPR) Rate | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 | 
| Partial Response (PR) Rate | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL). | Up to Month 36 | 
| Percentage of Participants With Disease Progression or Death | Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. | Up to Month 36 | 
| Progression Free Survival (PFS) | 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). | Up to Month 36 | 
| Overall Survival (OS) | Defined as the time from first venetoclax intake to death from any cause. | Up to Month 36 | 
| Treatment Duration | Overall treatment duration of venetoclax. | Up to Month 36 | 
| Time to Progression (TTP) | Defined as the period from first venetoclax intake until objective disease progression (until disease progression or death due to progression, whichever occurs first). | Up to Month 36 | 
| Change in Patient Reported Outcomes | 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. | From Baseline (Week 0) Up to Month 36 | 
| Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) | Determined by assessment of peripheral blood or bone marrow after treatment. | Up to Month 36 | 
| Percentage of Participants with Dose Modifications | Dose modifications include interruptions during ramp-up and maintenance phase. | Up to Month 36 | 
| Percentage of Participants with Adverse Drug Reactions (ADR) | 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. | Up to Month 36 | 
| Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia | Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia. | Up to Month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukemia Venetoclax Relapsed/Refractory