A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study)

Study Overview
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Brief Summary
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This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.

Official Title
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Prospective Non-interventional Study to Describe the Effectiveness and Safety of Venetoclax in Acute Myeloid Leukemia (AML) Patients in Routine Clinical Practice (REVIVE Study)

Conditions
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Acute Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health. Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study. Exclusion Criteria: - Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.

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<br>Participants in this observational study will receive treatment with venetoclax for AML. The decision to treat with venetoclax has been made independently from this observational study before participants are offered the opportunity to participate in this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is defined as the time from the date of first treatment to the date of death from any cause. | Time from treatment to death from any cause, up to approximately 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving composite complete remission (CR or CRi) | The percentage of participants achieving CR or CRi will be calculated based on the modified International Working Group (IWG) criteria for AML. | Approximately 30 months | 
| Time to transfusion independence | Transfusion independence is defined as the time between date of first venetoclax treatment and absence of red blood cell (RBC) or platelet transfusion for any consecutive 8 and/or 16 week period. | Up to 30 months | 
| Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) | The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (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 0 to 1 representing the general health status of the individual, with higher scores indicating better health state. | Week 0 to approximately 30 months | 
| Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics | The percentage of participants treated with venetoclax in combination with Hypomethylating Agents (HMAs) and Low Dose Cytarabine (LDAC) will demonstrate treatment patterns of prescribing physicians. | Up to approximately 30 months | 
| Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30) | EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). | Week 0 to approximately 30 months | 
| Percentage of participants achieving transfusion independence | Transfusion independence is defined as the time between date of first venetoclax treatment and absence of red blood cell (RBC) or platelet transfusion for any consecutive 8 and/or 16 week period. | Up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Venetoclax