Multicenter Assessment of Treatment Outcomes in a Historical Cohort of Patients with Relapsed or Refractory Acute Myeloid Leukemia (20180232) (Retrospective relapse/refractory AML outcomes)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Patient outcomes

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Acute myeloid leukaemia

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • 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)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To estimate the proportion of patients achieving hematological complete remission (CR) following salvage treatment for relapsed or refractory (R/R) acute myeloid leukemia (AML).
• Outcomes:
  Complete remission after salvage therapy, Complete remission with incomplete hematologic recovery, best response, remission duration, stem cell transplant proportion, overall survival, event free survival
• Data analysis plan:
  Descriptive analysis of complete remission proportions (N CR/N received therapy), duration of complete remission, event free survival, overall survival, stem cell transplant proportion.