Drug Use Investigation for Arzerra Chronic Lymphocytic Leukemia (CLL) (116789)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multicenter observational study

Study drug and medical condition

• Name of medicine:
  ARZERRA
• Medical condition to be studied:
  Chronic lymphocytic leukaemia

Population studied

• Short description of the study population:
  The study involved a multicenter observational investigation of Arzerra, a drug used to treat relapsed or refractory chronic lymphocytic leukemia. The target sample size was 300 patients, and data was obtained after administration under actual use conditions. A central registration system was adopted for patient enrollment. ; Patients who received Arzerra for the indication of relapsed or refractory CD20-positive chronic lymphocytic leukemia were included in the study. Patients who started receiving Arzerra before the study contract concluded were also considered study patients.
• Age groups:
  Adolescents (12 to < 18 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:
  Hepatic impaired

  Immunocompromised

  Other

  Pregnant women

  Renal impaired
• Special population of interest, other:
  Patients with chronic lymphocytic leukemia
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  This investigation will be conducted to collect and evaluate information regarding the safety and efficacy of Arzerra under the actual post-marketing use conditions of the product.
• Outcomes:
  Information regarding the safety and efficacy of Arzerra under the actual post-marketing use conditions of the product.
• Data analysis plan:
  Items related to patient disposition, patient demographic and baseline characteristics, items related to safety, and items related to efficacy