EPROS - Disease Registry Salvage Antiviral Therapy post HSCT
Research type
Research Study
Full title
European Patient Registry on Salvage Antiviral Treatment for Patients Experiencing Adenovirus and / or Cytomegalovirus Reactivation Post Allogeneic Hematopoietic Stem Cell Transplantation
IRAS ID
201261
Contact name
Anke Friedetzky
Contact email
Sponsor organisation
Cell Medica Ltd
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The study is a disease registry which aims to look at multiple outcome points in patients who have had a stem cell transplant and then had to be treated for a viral infection (in particular CMV or ADV) which did not respond to initial treatment (called salvage therapy).
Two particular viral infections will be assessed - CMV and ADV. Both of these are common viral infections in the general population, typically causing low morbidity and low mortality. However in an immunosuppressed patient, they can result in high morbidity with a variety of complications. Infections are the second leading cause of death after bone marrow transplantation and patients often require extensive treatment and hospital care. In children ADV poses the biggest risk with a high mortality rate in children who develop ADV disease.
Patients will have exhibited viral infection, been treated and now require additional treatment for that viral infection - either as first treatment did not work, or was insufficient.
Treatments available include antiviral drugs and cellular therapies. The Registry will look at a minimum of 40 patients who were treated with Cell Medica adoptive cellular therapy and at least 40 patients who had standard antiviral drug therapy.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0178
Date of REC Opinion
22 Apr 2016
REC opinion
Favourable Opinion