DARWIN EU® - Real-World Overall Survival in Patients with Acute Gut GvHD Following Failure of Corticosteroids and Ruxolitinib

16/07/2026
20/08/2026
EU PAS number:
EUPAS1000001062
Study
Ongoing
Subscribe
Download as PDF
Study summary
Click on the image to enlarge
Study identification

EU PAS number

EUPAS1000001062

Study ID

1000001062

Official title and acronym

DARWIN EU® - Real-World Overall Survival in Patients with Acute Gut GvHD Following Failure of Corticosteroids and Ruxolitinib

DARWIN EU® study

Yes

Study countries

Belgium
Denmark
Germany
Spain
United States

Study description

Acute graft-versus-host disease (aGvHD) is a serious complication of allogeneic haematopoietic stem cell transplantation (allo-HSCT). Intestinal involvement is associated with severe disease, poor prognosis, and frequent resistance to first-line corticosteroid therapy. Failure of second-line treatments with ruxolitinib further limits therapeutic options and is associated with poor outcomes. However, evidence on treatment patterns and survival in routine clinical practice, particularly following failure of corticosteroids and ruxolitinib, remains limited. This study aims to generate real-world evidence on treatment use and survival outcomes among patients with aGvHD with intestinal involvement.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Marzyeh Amini

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable