Observational Study of Blinatumomab

  • STATUS
    Recruiting
  • End date
    Mar 22, 2024
  • participants needed
    300
  • sponsor
    Amgen
Updated on 2 August 2021

Summary

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

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.

Details
Condition Blincyto Use in Routine Clinical Practice
Clinical Study IdentifierNCT03117621
SponsorAmgen
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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