Retrospective Multicenter Study Describing Baseline Clinical Characteristics and Outcomes in BLINCYTO® Treated Adult Patients With Relapsed or Refractory B-cell Precursor ALL Stratified by Baseline Disease Burden and Cytoreductive Therapy (20200012)

Study type

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

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Acute lymphocytic leukaemia
• Additional medical condition(s):
  Relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Population studied

• Age groups:
  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)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The main objective of this study is to describe outcomes of blinatumomab treatment among four groups of subjects.
• Outcomes:
  Estimate proportion of patients receiving complete remission (CR) following blinatumomab treatment for relapsed or refractory acute lymphoblastic leukemia (R/R ALL) by baseline disease burden and cytoreductive therapy patient subgroups. Estimate disease-related patient outcomes and adverse events by baseline disease burden and cytoreductive therapy patient subgroups.
• Data analysis plan:
  This study is a retrospective analysis of treatment outcomes among subject with relapsed or refractory B-cell precursor treated with blinatumomab. Descriptive summaries of subject characteristics among all subjects and among four groups (Groups 1-4) will be generated from all covariates. Counts and proportions with 95% confidence intervals (CIs) will be estimated for binary/categorical endpoints. Continuous endpoints will be described using means, standard deviations, medians and interquartile ranges, minima, and maxima. Time-to-event endpoints will be estimated with Kaplan-Meier (KM) curves and medians with associated 95% CIs, 6-month and 12-month survival proportions with associated 95% CIs will also be estimated.