Granulocyte Augmented Cord blood transplantation for leukaEmia (GRACE)
Research type
Research Study
Full title
A multi-centre Phase I/II trial of granulocyte-augmented cord blood transplantation for young adults with very poor risk acute myeloid leukaemia.
IRAS ID
357519
Contact name
Mark Williams
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Allogeneic stem cell transplantation is the only potentially curative therapy for patients with high-risk acute myeloid leukaemia, but relapse is common and remains the leading cause of death. Patients with certain mutations and those transplanted without first clearing their disease have very poor outcomes with most relapsing soon after transplant then surviving only a few months. A recent trial at the Royal Manchester Children’s Hospital used cord blood stem cells alongside a type of white blood cell called ‘granulocytes’ and produced surprisingly good outcomes for children with very resistant leukaemia.
GRACE is a clinical trial for adults (<55 years) with acute myeloid leukaemia that has not responded to chemotherapy or harbours mutations that predict a very poor response to conventional transplant. Participants will receive a transplant using umbilical cord blood and be given additional infusions of white blood cells, called granulocytes. The trial will be split into two parts:
-The first will study the safety of this new approach. Our experience in children is that granulocyte infusions cause a fever, rash and expansion of another type of white blood cell called lymphocytes. Children that did not have this reaction did not respond to treatment. We therefore believe that the reaction is necessary for the treatment to work, but we must ensure that it is safe in adult patients. Our trial design allows us to determine the dose of granulocytes that is best tolerated and most likely to be effective.
-The aim of the second part is to demonstrate that the new treatment is more effective than conventional transplantation.
The study will be conducted in three NHS transplant centres. Patients will be recruited over 36 months and followed up for a minimum of 1 year. The study is funded by Blood Cancer UK.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0223
Date of REC Opinion
23 Aug 2025
REC opinion
Favourable Opinion