Pilot of Allogeneic Immunotherapy in Refractory Disease (PAIReD)
Research type
Research Study
Full title
Phase II Study of Reduced Intensity Allogeneic Transplantation for Refractory Hodgkin Lymphoma(PAIReD)
IRAS ID
7021
Contact name
Karl Peggs
Sponsor organisation
University College London
Eudract number
2008-004956-60
Clinicaltrials.gov Identifier
Research summary
Hodgkin lymphoma is a cancer of the lymphatic system, which usually has a good prognosis with chemotherapy treatment. However, patients who are refractory to multi-agent induction chemotherapy (either at diagnosis or at relapse) have a poor prognosis. Only a small proportion of these patients (<20%) obtain long-term disease-free survival with high dose therapy and autologous stem cell transplantation (ASCT). Conventional CT scanning detects a decrease in the size of tumour masses, but cannot differentiate active lymphoma from residual radiographic abnormalities with no active disease. Combining CT scanning with functional imaging (PET scanning) allows the identification of patients with chemosensitive but refractory disease. Better disease control is likely to be achieved by allogeneic transplantation, but full conditioning regimes are very toxic and have a high mortality. Reduced intensity conditioning (RIC) regimes have been used with much lower toxicity, but often with poor long term progression free survival in patients with refractory disease. Recently, the BEAM-Alemtuzumab regimen has been used in relatively small numbers of this group of patients. This regimen is at the more intensive end of the reduced intensity spectrum, and as such has been associated with increased transplant related mortality when used following prior ASCT. The increased dose intensity is likely to be beneficial when treating chemorefractory cases. In this study, the BEAM-Alemtuzumab regimen will be used at an earlier stage of the disease, without prior ASCT, in poor prognosis individuals, to determine disease free survival.
REC name
London - London Bridge Research Ethics Committee
REC reference
09/H0804/74
Date of REC Opinion
14 Aug 2009
REC opinion
Further Information Favourable Opinion