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.