Transplantation of Umbilical Cord Blood from Unrelated Donors in Patients with Haematological Diseases using a Reduced Intensity Conditioning Regimen
Description
Design:
RIC-UCBT is a multicentre phase II single-arm trial of reduced-intensity conditioned umbilical cord blood transplantation in patients with haematological diseases.
Treatment:
All patients registered received a fludarabine, cyclophosphamide & low-dose total body irradiation conditioned cord blood transplant, followed by standard immunosuppression. They were followed up regularly for at least 2 years post-transplant.
Key inclusion/exclusion criteria:
Patients aged 2-70 years with advanced or high risk haematological diseases (e.g. leukaemia, lymphoma, myeloma, myelodysplastic syndrome) needing transplant, who do not have a matched sibling or unrelated donor available. They must not have had a stem cell transplant within the previous 6 months, and have to be fit for transplant, with adequate liver, kidney, heart and lung function. Patients must not have progressive or refractory disease. Patients with serious active infection or who test positive for HIV or HTLV are not eligible.
Duration of recruitment:
40 months
Aim
The overall aim of the RIC UCBT trial is to investigate whether reduced intensity cord blood transplantation is safe and effective in controlling haematological diseases. The study investigates rates of transplant-related mortality, graft-versus-host disease, engraftment, as well as disease progression and survival.