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, and 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. The experience of the investigators 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. The investigators therefore believe that the reaction is necessary for the treatment to work, but the investigators must ensure that it is safe in adult patients. The trial design allows the investigators 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.
Age range
16 Years – 55 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Frequency and Severity of Cytokine Release Syndrome (CRS)
Timeframe: Day 0 (day of allograft) to Day 28 post allograft
Frequency and Severity of Acute Graft vs Host Disease
Timeframe: Day 0 (day of allograft) to Day 100 post allograft
Frequency and Severity of Chronic Graft vs Host Disease
Timeframe: Day 100 post allograft to Day 360 post allograft
Frequency of Transplant Related Mortality (TRM)
Timeframe: Day 0 (day of allograft) to Day 100 post allograft
Frequency of Primary Graft Failure
Timeframe: Day 0 (day of allograft) to Day 28 post allograft
Rate of Relapse-Free Survival (RFS)
Timeframe: Day 0 (day of allograft) to Day 360 post allograft