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Multi-centre retrospective study to describe the use and outcomes of ECP in combination with new treatment protocols in Acute and Chronic GvHD

Transplant Complications Working Party (TCWP)
Study number:
2019000902
Diseases:
 
Short title:
ECP combination Study
Study status:
In preparation
Deadline for data collection:
Study design:
It is a multi-centre and retrospective registry based study. The data will be collected covering up to 3 years of follow-up from 2017 onwards, from onset GVHD that has failed to respond to steroids.
Primary objective:
The primary objective of the study is to compare and to evaluate the safety and efficacy of patients receiving ECP and/or new treatments in acute and chronic GvHD
Key inclusion criteria:
-Adult patients;
-Patients who develop acute SR-GvHD after first HSCT and there is a minimum of 6 months follow up data in the database
Patients who initiate treatment with ECP or Ruxolitinib within 60 days of onset of SR aGvHD
aGVHD Grade: II-IV only at time of treatment initiation
-Patients who develop chronic SR-GvHD after first HSCT and there is with a minimum of 1 year follow up data in the database
Patients who initiate treatment with ECP or Ruxolitinib or Ibrutinib within 1 year of the onset of SR-cGvHD
cGVHD Severity: moderate to severe only at time of treatment initiation



Country:
 
Principal investigator:
Dr. Olaf Penack
Principal investigator email:
 
EBMT Study coordinator:
Jessica Lemaitre
Study coordinator email:
jessica.lemaitre@upmc.fr