Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, Cancer, Venetoclax: Venclyxto, ABT-199
Brief summary
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* The participant received a diagnosis for acute myeloid leukemia (AML). * The participant was initiated on the studied line of therapy for previously untreated AML, as noted in the protocol. * The participant was treated with the studied line of therapy at least 28 days prior to date of data collection. * Information on the participant's treatments, selected (or important) clinical characteristics, and outcomes is available from the start of the studied line of therapy onwards.
Exclusion criteria
* The participant received the studied line of therapy as part of a clinical trial. * Participant received prior lines of therapy for AML. * The participant has a history of malignancies within 2 years prior to the studied line of therapy, other than AML, and with the exception of what is noted in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 10 Months | OS will be measured as the number of days between the initiation of the studied line of therapy and death. |
| Event-free survival (EFS) | Up to 10 Months | 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. |
| Percentage of Participants Achieving Best Overall Response | Up to 10 Months | 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. |
| Duration of Response (DoR) | Up to 10 Months | 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. |
| Percentage of Participants with Transfusion Independence (TI) | Up to 10 Months | TI from initiation of the studied line of therapy until disease progression, refractory disease, relapse, or switch to a new line of therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Healthcare Resource Utilization (HRU) | Up to 10 Months | 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. |
Outcome results
None listed