Healthcare Providers’ Awareness of the risks and safe use conditions associated with BLINCYTO®: A REMS Assessment Survey (20170108)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32897
• EU PAS number:
  EUPAS19116
• Study ID:
  32897
• Official title and acronym:
  Healthcare Providers’ Awareness of the risks and safe use conditions associated with BLINCYTO®: A REMS Assessment Survey (20170108)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This cross-sectional study is to evaluate the effectiveness of the BLINCYTO Risk Evaluation and Mitigation Strategy (REMS) Program among healthcare providers (HCPs) who have used BLINCYTO for patients in the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) and B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) in the United States. Specifically, the study is to determine the level of awareness and understanding of the key risks (cytokine release syndrome, neurologic toxicities, and preparation and administration errors,) and safe use conditions associated with BLINCYTO therapy. The REMS surveys were conducted at 18 months and 3 years, and will be conducted at 5 years and 7 years after the launch of BLINCYTO. In this 5-year survey, at least 300 completed surveys will be targeted, including at least 100 prescribers, 100 nurses, and 100 hospital and/or home healthcare pharmacists. A threshold knowledge score of 80% will be used to evaluate a minimum acceptable level of understanding of the key risk messages.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 29/03/2019

Actual: 29/03/2019

Study start date

Planned: 21/08/2019

Actual: 25/09/2019

Data analysis start date

Planned: 21/09/2019

Actual: 15/10/2019

Date of final study report

Planned: 06/12/2019

Actual: 14/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

Protocol 2017-04-20 redaction 2017-05-23

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only