Study identification

PURI

https://redirect.ema.europa.eu/resource/49266

EU PAS number

EUPAS37395

Study ID

49266

Official title and acronym

Retrospective Multicenter Study Describing Baseline Clinical Characteristics and Outcomes in BLINCYTO® Treated Adult Patients With Relapsed or Refractory B-cell Precursor ALL Stratified by Baseline Disease Burden and Cytoreductive Therapy (20200012)

DARWIN EU® study

No

Study countries

United States

Study description

This observational retrospective study will be conducted at 5 sites. Around 200 subjects with relapsed or refractory B-cell precursor acute lymphoblastic leukemia who have initiated treatment with blinatumomab are planned to be included in this study. The planned study period is approximately 5 and a half years. Information will be collected to describe the baseline and clinical characteristics among the subjects. The study was cancelled on July 31, 2022

Study status

Planned
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Memorial Sloan Kettering Cancer Center New York, USA, City of Hope California, USA, Cleveland Clinic Ohio, USA, University of California San Francisco California, USA, Fred Hutchinson Cancer Center Washington, USA

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol

Protocol-Published Original blinatumomab 20200012 .pdf

English (3.35 MB - 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