Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia

Study Overview
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Brief Summary
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Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice. Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan. Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets. There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.

Official Title
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A Post-marketing Observational Study for Venetoclax in Patients Diagnosed With Acute Myeloid Leukemia in Japan

Conditions
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Acute Myeloid Leukemia (AML)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All participants who are administered venetoclax for treatment of AML. 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 |
| --- | --- |
| Participants Treated With Venetoclax<br>Participants who are administrated venetoclax for treatment of AML under routine clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML) | Percentage of participants with a high grade (≥ Grade 3) protocol specified neutropenia during and after treatment with venetoclax. | Up to 52 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Febrile Neutropenia and Thrombocytopenia | Percentage of participants with protocol specified febrile neutropenia and thrombocytopenia during and after treatment with venetoclax. | Up to 52 weeks | 
| Percentage of Participants With Tumor Lysis Syndrome (TLS) | Percentage of participants with protocol specified TLS during and after treatment with venetoclax. | Up to 52 weeks | 
| Percentage of Participants Reported >= Grade 3 Adverse Events (AE)/Adverse Drug Reactions (ADR) | Grade 3 and above AE/ADR are serious adverse event (SAE) 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. | Up to 52 weeks | 
| Percentage of Participants Reported Adverse Events (AE)/Adverse Drug Reaction (ADR) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. | Up to 52 weeks | 
| Percentage of Participants With AE/ADR When Used Concomitantly With CYP3A Inhibitors or Growth Colony Stimulating Factor (G-CSF) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. | Up to 52 weeks | 
| Percentage of Participants With Composite Complete Remission Rate (CR + CRi) | Composite Complete remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol criteria. | Up to 52 weeks | 
| Median Time to Best Response | Time to Best Response is measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better. | Up to 52 weeks. | 
| Median Treatment Duration | Median time for duration of oral venetoclax treatment in participants with Acute Myeloid Leukemia. | Up to 52 weeks | 
| Median Overall Survival | Time from the date of first oral Venetoclax intake to the date of death from any cause. | Up to 52 weeks | 
| Median Duration of Composite Complete Remission | Time from the date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi). | Up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia (AML), Cancer, Venetoclax, Venclexta, Venclyxto