All Case Post Marketing Drug Use Result Survey for Blinatumomab in Japan (20170655) (Blinatumomab All Case PMS Japan)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28461
• EU PAS number:
  EUPAS26530
• Study ID:
  28461
• Official title and acronym:
  All Case Post Marketing Drug Use Result Survey for Blinatumomab in Japan (20170655) (Blinatumomab All Case PMS Japan)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  To assess the risk factors of neurologic events, the treatment for Cytokine release syndrome (CRS) and the incidence of each safety concerns in the patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) for treatment of blinatumomab in a real world medical practice in Japan, with particular focus on the safety specifications as described in Japanese Risk Management Plan, Neurologic events, CRS, Infections and Pancreatitis as important identified risks.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 250 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 27/11/2018

Actual: 19/12/2018

Study start date

Planned: 22/02/2019

Actual: 19/02/2019

Data analysis start date

Planned: 30/09/2023

Actual: 07/09/2022

Date of final study report

Planned: 31/03/2024

Actual: 19/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Study_20170655_Blinatumomab_Japan_PMS_Protocol_Amgen Format_ver1.0

Regulatory

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