Real-World Observational Study of Outcomes for Acute Myeloid Leukemia (AML) Patients Treated With Glasdegib or Venetoclax in US Community Oncology Practices

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Treatment Patterns
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  DAURISMO
• Medical condition to be studied:
  Acute myeloid leukaemia

Population studied

• Short description of the study population:
  All patients treated by the providers with a GLAS-based regimen were identified during study feasibility. Unique identification numbers were then assigned to each patient. Cardinal Health randomized these patients and provided links to the eCRF in the random order they were sorted. Providers completed data abstraction sequentially according to the randomization order until all eligible patients were completed, or the provider was not able to perform data collection.; ; Inclusion criteria; Patients must have met all the following inclusion criteria to be eligible for inclusion in the study. Providers were asked to confirm the criteria are met by answering a set of questions in the patient eligibility portion of the eCRF which correspond to these criteria. Automatic date and logic checks were employed to ensure that a patient identified was eligible for the study.; For this study, the following inclusion criteria were used:; • Patients newly diagnosed with AML.; • Initiated 1L or later therapy (i.e., index therapy) for newly diagnosed AML with GLAS-based regimen or initiated 1L therapy with VEN-based regimen in the following time periods*; o Initiated 1L or later therapy for AML with GLAS-based regimen between 01 December 2018 and 31 December 2019.; o Initiated 1L therapy for AML with VEN-based regimen between 01 December 2018 and 31 December 2019.; • ≥18 years of age at index therapy initiation.; • ≥6 months of follow-up from initiation of index therapy unless died, with known date of death.; • Known cytogenetic risk profile at the time of index therapy.; • ≥1 bone marrow biopsy completed following index therapy initiation.; ; Exclusion criteria; Patients meeting any of the following criteria were not included in the study:; • Patients who received treatment for AML as part of a clinical trial.; • Patients with diagnosis of any other malignancy (except for non-melanoma skin cancer) at the time of treatment of AML.; o Patients with diagnosis of AML and non-melanoma skin cancer at the time of treatment of AML were not excluded.; • A patient with a record of 1 or more of the following confounding diagnoses at any time during data availability: acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; or gastrointestinal stromal tumors.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Acute Myeloid Leukemia (AML) Patients
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  Understand patient demographic, clinical, and disease-related characteristics of AML patients who initiated treatment with GLAS-based regimen. Assess treatment patterns of AML patients who initiated treatment with GLAS-based regimen Estimate clinical outcomes of AML patients who initiated treatment with GLAS-based regimen.
• Outcomes:
  Disease response, Transfusion independence (TI), event-free/relapse-free survival (EFS/RFS), and overall survival (OS) for AML patients treated with GLAS-based regimen
• Data analysis plan:
  Each cohort will be described independently, no comparisons of patient characteristics or outcomes between GLAS- and VEN-treated patients will be conducted. The primary clinical outcomes of interest include TI, duration of therapy, disease response, duration of response, EFS, RFS, and OS. Time to event outcomes will be analyzed using the Kaplan-Meier method. Comparisons of time to event outcomes will be made using a Cox proportional hazards model or other parametric techniques as appropriate. Experience of toxicities will only be described for the VEN-treated cohort. Details of the data analysis will be provided in the statistical analysis plan.