A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation

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 standard induction therapy in Russian Federation. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.

Official Title
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Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Acute Myeloid Leukemia (AML) Patients Ineligible for Standard Induction Therapy in Routine Clinical Practice in Russian Federation (INNOVATE)

Conditions
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Acute Myeloid Leukemia (AML)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed acute myeloid leukemia (AML) (de novo or secondary) and eligible to receive Venetoclax as per Russian Ministry of Health label Ineligible for standard induction therapy with cytarabine and anthracycline Eastern Cooperative Oncology Group (ECOG) score >2 White blood cell counts <25 x 109 per liter Started Venetoclax within 4 weeks of enrolling in study Exclusion Criteria: Acute promyelocytic leukemia Contraindications to Venetoclax as listed on the approved local label in Russian Federation Neuroleukemia - active central nervous system (CNS) involvement Participation in a clinical trial with an investigational drug for AML 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. Decision to treat with Venetoclax was made prior to offering participation in this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Defined as the time (in days) between the date of first Venetoclax intake to date of death. | Approximately 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Defined as the percentage of participants with either complete response (CR) or complete response with incomplete hematological recovery (CRi) according to physician's assessment. | Approximately 18 months | 
| Best Overall Response Rate | Defined as the percentage of participants with either CR or CRi according to physician's assessment during Venetoclax treatment. | Approximately 18 months | 
| Best complete Remission | Defined as the percentage of participants with CR according to physician's assessment during Venetoclax treatment. | Approximately 18 months | 
| Time to First Response | Defined as the time (in weeks) between the date of first Venetoclax intake to first response, among CR, CRi, and morphologic leukemia free state (MLSF). | Approximately 18 months | 
| Time to Best Response to Treatment | Defined as the time (in weeks) between the date of first Venetoclax intake and the date of hte assessment having documented the best response among CR, CRi, and MLSF. | Approximately 18 months | 
| Duration of Response (DOR) | Defined as the time (in weeks) between the date of the first assessment documenting the response to Venetoclax (either CR, CRi, or MLSF) and the date of the first assessment having documented the progression. | Approximately 18 months | 
| Event-Free Survival (EFS) | Defined as the time (in weeks) between the date of first Venetoclax intake and the date of the first assessment having documented disease progression (primary refractory disease, or relapse from CR, CRi, or death from any cause). | Approximately 18 months | 
| Relapse-Free Survival (RFS) | Defined as the time between the date of CR and the date of the first assessment having documented disease progression or death from any cause. | Approximately 18 months | 
| Time to Transfusion Independence | Defined as the time (in weeks) between the date of first Venetoclax intake and the absence of any red blood cell (RBC) or platelet transfusion during any consecutive 8 weeks during the treatment period. | Approximately 18 months | 
| Percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs) | Defined as the percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs). | Approximately 18 months | 
| Percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC) | Defined as the percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC). | Approximately 18 months | 
| Percentage of participants treated with Venetoclax in combination with other therapeutic agents | Defined as the percentage of participants treated with Venetoclax in combination with other therapeutic agents | Approximately 18 months | 
| Percentage of participants with dose modifications | Percentage of participants with dose modifications. | Approximately 18 months | 
| Percentage of participants with dose interruptions | Percentage of participants with dose interruptions | Approximately 18 months | 
| Percentage of participants taking concimtant CYP3A medications | Percentage of participants taking concimtant CYP3A medications while treated with Venetoclax. | Approximately 18 months | 
| 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 18 months | 

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