Acute myeloid leukemia
Conditions
Interventions
None listed
Sponsors
AbbVie Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult(>= 18 years old) male or female diagnosed with primary or secondary AML Deemed ineligible for intensive induction chemotherapy because of age, performance status, comorbidities as defined by treating physician Have received systemic therapy including low intensity chemotherapy, targeted therapy or BSC for AML in the 1L setting During the treatment period, patients must have >= 2 visits in addition to the initial event visit(referred to as the index date, defined as start of low intensity chemotherapy or BSC) -Visits are defined as physical encounters with the practice, detected by vital sign records; -The second and third visits must be observed after the index date to demonstrate continuity of care; -There is no required time span between the additional visits and the index date
Exclusion criteria
Exclusion criteria: AML diagnosis not confirmed Acute Promyelocytic Leukemia Received First line AML treatment within a clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) OS will be defined as the time (in months) from the date of confirmed diagnosis of AML (i.e., the index date) to death (any cause) as documented in the medical chart. Patients who did not die within the study observation period will be censored on the study end date or the last contact date available in the dataset, whichever occurred first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival(PFS) PFS is measured from the date of confirmed diagnosis of AML to the date of physician-assessed disease progression or death due to any cause. Time to Treatment failure(TTF) TTF is measured as the time from start of systemic therapy including LIC, targeted therapy or BSC until discontinuation of the treatment for any reason including disease progression, death, toxicity, or patient or physician choice. Healthcare Resource Utilization(HRU) HRU will be descriptively assessed as the median number of times the patients receive transfusions (differentiating RBC and platelet transfusions), median number of days hospitalized or admitted to ICU, the median number of Outpatient consultations, supportive care received (e.g., growth factors), antibiotics use for infections and other medications (e.g., CYP3A inhibitors) following initiation of low intensity chemotherapy, targeted therapy or BSC until discontinuation of this initial treatment for any reason. MRD Testing rates including methodology as available Detectable residual leukemic cells are referred to as Measureable Residual Disease (MRD; formerly Minimal Residual Disease). MRD can be measured using multiparameter flow cytometry, or real-time quantitative polymerase chain reaction (RT-qPCR) or Next Generation Sequencing. MRD testing rates will be collected based on current clinical practice, and methodology of testing will be collected if applicable. It is possiblethat patients have multiple MRD response assessments in their charts during this period. All documented responses (along with the associated progress note date) will be captured. For purpose of analysis, only best response will be used. Response Rate per Physician Assessment Rates of Complete Remission(CR), time to achieve CR, duration of CR, CR with incomplete hematologic recovery (CRi), Morphologic Leukemia Free State, Partial Remission, and Treatment Failure will be captured, per physician assessment. | — |
Countries
Japan,Asia(except Japan),North America,South America,Australia,Europe
Contacts
Public ContactHarumi Mukai
AbbVie GK Medical
Outcome results
None listed