A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia

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 in combination with azacitidine works to treat AML in adult participants in Colombia. Venetoclax in combination with azacytidine is approved to treat Acute myeloid leukemia (AML). All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 70 participants will be enrolled in the study in Colombia. Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) or intravenous (IV) injection 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.

Official Title
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Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice

Conditions
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Acute Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed acute myeloid leukemia (AML) defined as participants that have histological confirmation of AML (de novo, secondary) by World Health Organization (WHO) criteria, and have not received any prior treatment for AML. Ineligible to intensive chemotherapy due to >=75 years of age; or >=18 to 74 years who have comorbidities that preclude use of intensive induction chemotherapy. Participants starting treatment with venetoclax in combination with azacytidine treated according to the Colombia label and who are not completed the first cycle (Cycle 28 days). Exclusion Criteria: - Participating 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 + Azacitidine Participants<br>Participants treated with venetoclax in combination with azacitidine 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 defined as the time from the date of start Venetoclax to the date of death from any cause. | Up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Complete Remission (CR) | CR is defined according to the modified International Working Group (IWG) criteria for acute myeloid leukemia (AML) as no morphologic evidence of AML and absolute neutrophil count >=10^3 /μL (>=1.0 x 10^9 /L), platelets >=10^5 /μL (>=100 x 10^9 /L), red blood cell (RBC) transfusion independence, and bone marrow with <5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. | Up to 18 Months | 
| Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (Cri) | Cri is defined according to the modified IWG criteria for AML as all criteria as CR except for residual neutropenia <10^3 /μL (1,000/ μL), or thrombocytopenia <10^5 /μL (100,000/ μL). If all criteria for CR are meet except for RBC transfusion independence, this also fulfills Cri criteria. | Up to 18 Months | 
| Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (CRh) | CRh is defined according to the modified IWG criteria for AML as bone marrow with < 5% blasts and Peripheral blood neutrophil count of > 0.5 × 10^3 /μL and Peripheral blood platelet count of > 0.5 × 10^5 /μL and 1-week (>= 7 days) platelet transfusion-free period prior to the hematology lab collection. | Up to 18 Months | 
| Percentage of Participants Achieving Transfusion Independence | Transfusion ndependence is defined as a period of at least 56 days with no transfusion between the first dose of Venetoclax and the last dose of Venetoclax plus 30 days. | Up to 18 Months | 
| Event-Free Survival (EFS) | EFS defined as the time from the date of start Venetoclax to the date of morphologic relapse, progressive disease, resistant disease, treatment failure, or death from any cause. | Up to 18 Months | 
| Duration of Remission (DOR) | DOR defined as the time from the date of first CR, CRi or CRh to the earliest evidence of morphologic relapse, progressive disease, or death due to disease progression. | Up to 18 Months | 
| Duration of Treatment (DoT) | DoT defined as the time from the start of a therapy to the time of treatment discontinuation for any reason. | Up to 18 Months | 
| Percentage of participants with Adverse Events (AE) | AE, defined as any unfavorable medical event that is temporarily related to the use of the investigational product, which does not necessarily have a causal relationship with the investigational product. | Up to 18 Months | 
| Percentage of participants achieving Minimal Residual Disease (MRD) negativity | MRD negativity, defined as having less than 10^-3 residual blasts per leukocyte measured in the bone marrow. | Up to 18 Months | 
| Change in Health-Related Quality of Life (HRQOL) Score | HRQOL score, defined as a multidimensional construct defined as the subjective perception of the life as a whole, including physical, emotional, social, cognitive functions, disease symptoms and side effects of treatment. | Up to 18 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, Azacitidine, ABT-199, Cancer