Study identification

EU PAS number

EUPAS13794

Study ID

40386

Official title and acronym

An observational study of patients with Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia in the US (20150253)

DARWIN EU® study

No

Study countries

United States

Study description

This observational cohort study aims to characterize current real-world treatment and outcomes among patients with Philadelphia chromosome-negative (Ph-) R/R ALL. The study will involve a series of reviews of medical records of patients initiating treatment for Ph- R/R ALL between January 2013 and March 2019 at approximately 20-30 selected clinical centers in the US. This study will describe patient characteristics and treatment patterns among Ph- R/R ALL patients. In addition, the study will assess drug utilization, healthcare resource utilization, and treatment effectiveness and safety among Ph- R/R ALL patients in the salvage treatment setting.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
University of Maryland Greenbaum Cancer Center Baltimore, MD, USA, University of Southern California, Norris Comprehensive Cancer Center Los Angeles, CA USA, McFarland Clinic Ames, IA, USA, City of Hope National Medical Center Duarte, CA, USA, NY Presbyterian/Weill Cornell Medical Center New York, NY, USA, University of Pennsylvania Philadelphia, PA, USA, Rush University Medical Center Chicago, IL, USA, Karmanos Cancer Institute Detroit, MI, USA, Thomas Jefferson University Hospital Philadelphia, PA, USA, John Theurer Cancer Center at Hackensack University Medical Center Hackensack, NJ, USA

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

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
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable