A Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice

Study Overview
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Brief Summary
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This study will evaluate effectiveness and safety in routine clinical practice in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

Official Title
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Post Marketing Observational Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice

Conditions
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Chronic Lymphocytic Leukemia (CLL)

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 who have been informed verbally and in writing about this study, and who do not object to their data being processed or subjected to data quality control. Exclusion Criteria: - Participants currently participating (or previously participated) in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

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 |
| --- | --- |
| 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 |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) and partial response (PR), according to physician's assessment. | Up to approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) or partial response (PR), according to physician's assessment. | Up to approximately 24 months | 
| Complete Response (CR) Rate | CR is defined as the proportion of participants with either CR and CRi, according to physician's assessment. | Up to approximately 24 months | 
| Time to Response (TTR) | 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 complete response, complete response with incomplete bone marrow recovery, nodular partial response, and partial response. | 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, and PR. | Up to approximately 24 months | 
| Overall Survival (OS) | Overall survival (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 | 
| 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 | 
| 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 Next Treatment | 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 | 
| Duration of Response (DOR) | DOR is calculated in the sub-population of patients experiencing treatment response (complete response, complete response with incomplete bone marrow recovery, nodular partial response or partial response) 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 | 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 | 
| Best Response under Next CLL Treatment | The best response under next CLL treatment is calculated in the sub-population of participants having a next CLL treatment after venetoclax discontinuation. | Up to approximately 48 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukemia, Cancer, venetoclax, observation