Study of graft versus host disease in HSCT patients
Research type
Research Study
Full title
Clinical and economic burden of graft versus host disease in allogeneic stem cell transplant recipients in the UK – A retrospective cohort Study
IRAS ID
321479
Contact name
Nadia Quignot
Contact email
Sponsor organisation
LA-SER EUROPE LIMITED (a Certara company)
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Approximately 1500 patients undergo allogeneic haematopoietic stem cell transplantation (allo-HSCT) for the treatment of blood disorders and cancers of the blood, such as leukaemia and lymphoma, per year in the United Kingdom. A common and serious complication of allo-HSCT is the development of Graft-versus-host-disease (GVHD), a condition in which transplanted cells attack the transplant recipient’s cells. While GVHD is known to be associated with a number of adverse health outcomes, there is currently limited contemporary evidence from the UK relating to the impact of the development of GVHD on patient health and the healthcare system. To help to fill this knowledge gap, a retrospective, observational study will be conducted using data from the National Cancer Registration and Analysis Service (NCRAS) and linked databases. From these databases, information will be extracted on adult (18 years or older) patients with cancer of the blood who underwent allo-HSCT between January 2011 and December 2020. Rates of severe infection and death, as well as the healthcare resource utilisation of each patient, such as number of hospitalisations and outpatient visits will then be compared among patients who did and did not develop GVHD. This information will be used to better understand the extent to which GVHD causes worse health outcomes and increases the burden on the healthcare system.
Information from this study will therefore help to improve the understanding of the consequences of GVHD and will help to highlight key public health priorities in the treatment of allo-HCST patients.
Lay summary of study results: This study looked at patients in England who received donor stem cell transplants, including those who did and did not develop graft-versus-host disease (GVHD), a known post-transplant complication. Over half of the patients developed GVHD, which was linked to higher death rates, more serious infections, longer hospital stays, and increased healthcare costs. These findings highlight the need for better ways to prevent and treat GVHD.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0037
Date of REC Opinion
27 Jan 2023
REC opinion
Favourable Opinion