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Strategic considerations
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Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.
Data from up to 700 participants will be collected. No participants will be enrolled in this study.
Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.
There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving Venetoclax | Participants with AML receiving venetoclax undergoing chart review. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS will be measured as the number of days between the initiation of the studied line of therapy and death. | Up to 10 Months |
| Event-free survival (EFS) | EFS will be measured as the number of days between the initiation of the studied line of therapy and disease progression, or refractory disease, or death. | Up to 10 Months |
| Percentage of Participants Achieving Best Overall Response | Physician-reported best response achieved from initiation of the studied line of therapy until the earliest of disease progression, refractory disease, relapse, switch to a new line of therapy, or end of follow-up or death. | Up to 10 Months |
| Duration of Response (DoR) | DoR is is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi), complete remission with partial hematologic recovery (CRh), morphologic leukemia-free state (MLFS); in days. | Up to 10 Months |
| Percentage of Participants with Transfusion Independence (TI) | TI from initiation of the studied line of therapy until disease progression, refractory disease, relapse, or switch to a new line of therapy. | Up to 10 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Healthcare Resource Utilization (HRU) | HRU is measured from initiation of the studied line of therapy until physician recorded disease progression, refractory disease, relapse, or switch to a new line of therapy. | Up to 10 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Participants with Acute Myeloid Leukemia (AML) being treated with venetoclax.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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