MoTD
Research type
Research Study
Full title
A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide
IRAS ID
268363
Contact name
Ronjon Chakraverty
Contact email
Sponsor organisation
The University of Birmingham
Eudract number
2019-002419-24
Clinicaltrials.gov Identifier
ERN_19-0795, Ethics self assessment number
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Stem cell transplantation from a matched sibling or unrelated donor (allo-SCT) is the only curative therapy for many children and adults with blood cancer. However allo-SCT remains associated with a number of life-threatening side effects, the most serious of which is ‘graft-versus-host disease’ (GvHD). This complication occurs when donor immune cells (the ‘graft’) see the patient’s healthy skin, gut or liver (the ‘host’) as foreign and attacks them. Patients currently receive a combination of drugs and antibodies to prevent GvHD. A number of new approaches have been developed to prevent GvHD. In this randomised trial patients undergoing stem cell transplantation will be randomly assigned to either the current standard approach for GvHD prevention or one of two new approaches with the potential to reduce the risk of GvHD. If the trial shows a possible benefit of one of the new treatments, we will plan to extend the study to a larger number of patients. We plan to recruit up to 400 patients from hospitals across the UK over a 4-year period. This trial aims to provide the necessary proof whether the treatment works in patients needing an allo-SCT and whether it improves the outcome for patients.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0195
Date of REC Opinion
11 Sep 2020
REC opinion
Further Information Favourable Opinion