A Study of the Safety and Efficacy of Venetoclax in Japanese Participants With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)

Study Overview
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Brief Summary
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This study will collect real-world safety and efficacy data from Japanese relapse/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) participants treated with venetoclax.

Official Title
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Post-Marketing All-Patient Drug Use Results Study for Venetoclax in Japanese Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)

Conditions
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Cancer, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Leukemia (SLL)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Prescribed and treated with venetoclax Exclusion Criteria: None
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 prescribed and treated with venetoclax. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Approximately 37 weeks | 
| Overall Incidence of Averse Drug Reactions (ADRs) of Tumor Lysis Syndrome (TLS), Bone Marrow Suppression, and Infections | Adverse drug reactions were defined as AEs of which a causal relationship with venetoclax could not be ruled out. Overall incidence of ADRs of special interest (TLS, bone marrow suppression, and infections) will be collected. | Approximately 37 weeks | 
| Incidence of Adverse Drug Reactions (ADR) | Adverse drug reactions were defined as AEs of which a causal relationship with venetoclax could not be ruled out. All grades of ADRs will be collected. | Approximately 37 weeks | 
| Incidence of TLS According to Physician Assessment | Incidence of TLS according to physician assessment. | Approximately 37 weeks | 
| Incidence of TLS According to Howard Criteria | Incidence of TLS according to Howard criteria which is a classification system of TLS. Laboratory results must show two or more unusual measurements within a 24-hour period. | Approximately 37 weeks | 
| Incidence of Bone Marrow Suppression | Incidence of bone marrow suppression including neutropenia (all grades) and febrile neutropenia. | Approximately 37 weeks | 
| Incidence of Infections | Incidence of infections. | Approximately 37 weeks | 
| Incidence of ADRs When Venetoclax is Used Concomitantly with CYP3A Inhibitors | Incidence of ADRs when venetoclax is used concomitantly with CYP3A inhibitors will be collected. | Approximately 37 weeks | 
| Number of Prophylactic Measures Used for TLS | Number and description of prophylactic measures used in real-world clinical practice for TLS will be collected. | Approximately 37 weeks | 
| Number of Monitoring Measures Used for TLS | Number and description of monitoring measures used in real-world clinical practice for TLS will be collected. | Approximately 37 weeks | 
| Number of Participants with Dose Modifications | Summary data will be collected for participants with dose modifications. | Approximately 37 weeks | 
| Number of Participants with Dose Interruptions | Summary data will be collected for participants with dose interruptions. | Approximately 37 weeks | 
| Number of Participants Who Discontinued Venetoclax | Summary data will be collected for participants who discontinued treatment with venetoclax. | Approximately 37 weeks | 
| Best Overall Response Rate (ORR) | Defined as complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR), nodular partial response (nPR) according to physician assessment based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines and Japanese Society of Hematology clinical guidelines. | Approximately 37 weeks | 
| Time to Best Response | Time to best response according to physician assessment based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines and Japanese Society of Hematology clinical guidelines. | Approximately 37 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed/Refractory, Cancer, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Leukemia (SLL), Venetoclax