Observational Study of Blinatumomab

Amgen

Status: Completed

Conditions: Blincyto Use in Routine Clinical Practice

Study type: Observational

Funder types: Industry

Identifiers

NCT03117621

20150136

Details and patient eligibility

About

An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.

Full description

The primary objective of this study is to characterize the safety of Blincyto in routine clinical practice. Blincyto effectiveness, medication errors, and utilisation; and select healthcare resource use while using Blincyto will also be described. Safety and effectiveness of Blincyto in specified subgroups of patients will also be assessed.

Enrollment: 279 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medical records of patients initiating Blincyto after country-specific reimbursement in routine clinical practice will be eligible for extraction.

Exclusion criteria

• Medical records of patients who have participated in Blincyto clinical trials will be excluded since their treatment will be prescribed by the study protocol unless the patient is receiving new Blincyto treatment outside the clinical trial.
• Medical records of patients participating in other Amgen non-interventional prospective studies in which safety endpoints are collected will be excluded.
• Medical records of patients who have received Blincyto via an expanded access/compassionate use program will be excluded.
• In countries where patient informed consent is required for access to their medical records, any patient who does not provide informed consent will be excluded.

Trial design

279 participants in 1 patient group

Patients initiating Blinatumomab

Description:

Patients initiating Blinatumomab after Country-Specific Reimbursement approval in routine clinical practice.