Study type

Study topic

Disease /health condition
Human medicinal product

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, observational, multi-centre study
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

BLINATUMOMAB

Medical condition to be studied

B precursor type acute leukaemia
Population studied

Short description of the study population

The study population involved patients with B-precursor acute lymphoblastic leukemia (ALL) treated with Blincyto reported from five countries: France, Italy, Spain, UK and Russia identified from the 1st January 2014 up until 30th June 2017.
Inclusion criteria:
- B-precursor ALL patients who have initiated Blincyto in an expanded access setting from 1st January 2014 up until 30th June 2017.

Exclusion:
- Patients enrolled in Amgen expanded access protocol 20130320.
- Patients who do not provide informed consent, where required per country regulations.
- Patient’s medical chart is not available for data extraction.

Age groups

Paediatric Population (< 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

Other

Special population of interest, other

Acute lymphoblastic leukemia patients

Estimated number of subjects

350
Study design details

Main study objective

The primary objective is to describe the clinical characteristics and treatment patterns of patients with B precursor acute lymphoblastic leukemia, having received Blincyto in the expanded access setting and identify clinically relevant subgroups

Outcomes

To describe the clinical characteristics and treatment patterns of patients with B precursor ALL, having received Blincyto in the expanded access setting and identify clinically relevant subgroups, To describe the effectiveness of Blincyto within identified subgroups as outlined in Section 9.6.2.5 of the protocol To describe Blincyto utilization within identified subgroups as outlined in Section 9.6.2.5 of the protocol

Data analysis plan

All analyses will be descriptive. Continuous variables will be summarized by mean, median, standard deviation, lower and upper quartiles, and minimum and maximum values. Categorical variables will be summarized by number and percentage of patients in each category. For categorical outcomes, 95% confidence intervals (CIs) will also bepresented where appropriate. For time-to-event endpoints, Kaplan-Meier (KM) curvesand KM proportions at select time points, the number of subjects with events and thenumber of subjects censored will be used to summarise the data. Analyses will bepresented by the identified clinically relevant subgroups (listed in Section 9.7.2.5 of the protocol and identified by means of the primary endpoints), country and year of Blincyto initiation.
Documents
Study results
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