A Real-world Evidence on Effectiveness and Safety of Blinatumomab in Patients With B-cell Acute Lymphoblastic Leukaemia

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective study

Population studied

• Short description of the study population:
  Patients with B-cell acute lymphoblastic leukaemia received treatment with blinatumomab between August 2021 and June 2023.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  A Real-world Evidence on Effectiveness and Safety of Blinatumomab in Patients With B-cell Acute Lymphoblastic Leukaemia
• Outcomes:
  This study showed that blinatumomab was effective in the treatment of patients with B-ALL in the frontline as well as relapsed settings and had a tolerable safety profile.
• Data analysis plan:
  In this retrospective observational study, data of patients with ND and R/R B-ALL who received at least one dose of blinatumomab between August 2021 and June 2023 were collected from electronic medical data of the Department of Haematology of the First Affiliated Hospital of Soochow, China. The primary endpoint of the study was the treatment pattern of blinatumomab therapy, including median treatment cycles, treatment days, and treatment discontinuation. Secondary endpoints included complete remission (CR) rate/CR with incomplete blood cell recovery (CRi), minimal residual disease (MRD) negativity after 2 cycles of treatment (complete MRD remission defined as MRD < 0.01%), median and 1-year event-free survival (EFS) rate, median and 1-year overall survival (OS) rate, duration of response (DOR) and adverse events (AEs).