Study Venetoclax Effectiveness and Real-Life Treatment Management in Participants With Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

Official Title
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Venetoclax in Chronic Lymphocytic Leukemia Effectiveness and Real-life Treatment Management

Conditions
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Cancer - Chronic Lymphocytic Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with diagnosed Chronic Lymphocytic Leukemia (CLL) and eligible for venetoclax as per label. Participants for whom the physician has decided to initiate CLL treatment with venetoclax. Participants the physician believes he can personally follow over all the study period. Participants who have been informed verbally and in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control. Exclusion Criteria: - Participating in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Patients with Chronic Lymphocytic Leukemia (CLL)<br>Patients with diagnosed CLL and eligible to venetoclax as per label | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 12 Months | The best response is defined as the best response observed during the first year of study treatment among the possible responses to treatment: Complete Response (CR), CR with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR), Partial Response (PR), Stable Disease (SD), or Disease Progression (DP). | Up to approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Next Treatment | The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation. | Up to approximately 48 months | 
| Time to First Response to Treatment (TTR) | The time to response to treatment (TTR) is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented the response among CR, CRi, nPR, and PR. | Up to approximately 24 months | 
| Minimal Residual Disease | The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction). | Up to approximately 24 months | 
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants who reach either CR, CRi, nPR, or PR to treatment, according to physician's assessment. | Up to approximately 24 months | 
| Change in Score of EuroQol 5 Dimensions (EQ-5D-5L) | The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions are used to compute a single utility index score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual. The EQ-5D-5L also contains a visual analog scale (VAS) to assess the subject's overall health. | Up to approximately 24 months | 
| Time to Best Response to Treatment | The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the assessment having documented the best response among CR, CRi, nPR, PR, SD, and DP. | Up to approximately 24 months | 
| Response Duration | The response duration will be calculated in the sub-population of participants experiencing treatment response (CR, CRi, nPR, or PR) from the date when response is first met to the date of first following documented progression. | Up to approximately 48 months | 
| PFS after Disease Progression Following Venetoclax Treatment | The PFS after disease progression following venetoclax treatment will be calculated in the sub-population of patients experiencing disease progression under venetoclax. The PFS following venetoclax treatment is defined as the time from the date of first next CLL treatment intake to the date of the following documented progression or death from any cause. | Up to approximately 48 months | 
| Overall survival (OS) | OS is defined as the time from the date of first venetoclax intake to the date of death from any cause. | Up to approximately 48 months | 
| Best Response under Next CLL Treatment | The best response under next CLL treatment will be calculated in the sub-population of patients having a next CLL treatment after venetoclax discontinuation. | Up to approximately 48 months | 
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression or death from any cause. | Up to approximately 48 months | 
| Time To Progression (TTP) | The Time To Progression (TTP) is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression. | Up to approximately 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venetoclax, Venclyxto, Cancer, Chronic Lynmphocytic Leukemia (CLL)