Expanded access of Blincyto® in patients with acute lymphoblastic leukaemia: a retrospective observational study (Neuf Study) (20160441)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50762
• EU PAS number:
  EUPAS19961
• Study ID:
  50762
• Official title and acronym:
  Expanded access of Blincyto® in patients with acute lymphoblastic leukaemia: a retrospective observational study (Neuf Study) (20160441)
• DARWIN EU® study:
  No
• Study countries:
  France

  Italy

  Spain

  United Kingdom
• Study description:
  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
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 55 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 09/06/2017

Actual: 07/09/2017

Study start date

Planned: 15/01/2018

Actual: 11/01/2018

Data analysis start date

Planned: 28/08/2018

Actual: 04/12/2018

Date of final study report

Planned: 30/09/2020

Actual: 14/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20160441 Summary Protocol V1.0

Updated protocol

EUPAS19961-23311

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable