A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada

Study Overview
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Brief Summary
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Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax works to treat AML in adult participants who are ineligible for intensive induction chemotherapy in Canada. Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive induction chemotherapy will be enrolled. Around 270 participants will be enrolled in the study in approximately 15 sites in Canada. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 36 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 36 months.

Official Title
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Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN)

Conditions
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Acute Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Acute Myeloid Leukemia (AML). Ineligible for intensive chemotherapy, determined by the physician's assessment of age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), comorbidities, regional guidelines, and institutional practice. Participant for whom the physician has decided to initiate venetoclax treatment in accordance with the local label. The decision to treat with venetoclax is made by the physician prior to any decision to approach the participant to participate in this study. Exclusion Criteria: - Participation 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 |
| --- | --- |
| Venetoclax Participants<br>Participants treated with Venetoclax in accordance with approved local label. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS as defined by number of days from start of treatment to the completion of treatment or death from any cause. | Up to 36 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Composite Complete Remission Rate | Composite Complete Remission Rate is defined as complete remission (CR) plus complete remission with incomplete hematologic recovery (CRi) as described by the modified International Working Group (IWG) criteria. | Up to 36 Months | 
| Event-Free Survival (EFS) | EFS as defined by number of days from start of treatment to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause. | Up to 36 Months | 
| Percentage of Participants with Presence Transfusion Independence | Transfusion Independence is defined as at least 8 and/or 16 consecutive weeks without an Red Blood Cell (RBC) or platelet transfusion during the treatment period. | Up to 36 Months | 
| Number of Participants with Transfusions | Number of Participants with transfusions (red blood cells and platelets). | Up to 36 Months | 
| Number of Participants with Change in Venetoclax Dose | Number of participants with change in venetoclax dose. | Up to 36 Months | 
| Number of Participants with Change in Other Medications | Number of participants with change in other medications. | Up to 36 Months | 
| Venetoclax Administration Setting | Venetoclax administration setting (in-patient vs. out-patient vs. at home). | Up to 36 Months | 
| Number of Hospital Admission | Number of hospital admission. | Up to 36 Months | 
| Number of Participants with Change in use of Antiinfectives | Number of participants with change in use of antiinfectives. | Up to 36 Months | 
| Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk | Number of participants with change in TLS risk. | Up to 36 Months | 
| Occurrence of any Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment as graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). | Up to 36 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, ABT-199, Cancer