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
First published:
21/02/2024
Institution
Multiple centres: 55 centres are involved in the study

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (80.76 KB - PDF)View document
Updated protocol
English (175.25 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable