90Y-antiCD66 monoclonal ab in childhood relapsed/refractory leukaemia
Research type
Research Study
Full title
90-Yttrium-labelled anti-CD66 monoclonal antibody as part of a reduced intensity conditioning regimen prior to allogeneic haematopoietic stem cell transplantation: an open label, dose escalating phase I study in children with relapsed/refractory leukaemia
IRAS ID
103551
Contact name
Paul Veys
Contact email
Eudract number
2013-000015-24
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Children affected by leukaemia who do not respond to conventional chemotherapy have a very poor prognosis and might need treatment intensification and a bone marrow transplantation (BMT).
Children who undergo BMT with evidence of leukaemia in their bone marrow have a higher risk of treatment failure due to leukaemia relapse after transplant.
Therefore new strategies are needed to eradicate leukemic cells prior to BMT in those children who do not respond to conventional treatment.
It is well documented that leukemic cells are sensitive to irradiation and higher doses of irradiation achieve better leukaemia control. Nevertheless increasing the dose of irradiation is associated with an increased toxicity and mortality after transplant.
Radioimmunotherapy provides a way to deliver high dose irradiation to the bone marrow (where leukaemia resides), while sparing normal organs and tissues from its toxicity.
This can be achieved by linking a radioactive molecule (Yttrium90) to an antibody that, once infused in the blood, will target marrow/leukemic cells.
The infusion of this antibody prior to BMT will deliver high doses of irradiation directly to the bone marrow and sites where leukemic blasts reside and this will offer an additional, potentially effective treatment to target leukaemia prior to BMT.
So far radioimmunotherapy has been studied mainly in adults with good results in terms of efficacy and toxicity, but there is not a lot of information on this treatment in children undergoing BMT.
We designed a trial that foresees the use of radioimmunotherapy prior to BMT in children affected by leukaemia which is either refractory to conventional treatment or has relapsed after a first BMT.
Children aged 1-18 years will receive increasing doses of irradiation delivered to their bone marrow, in order to find the maximum tolerated dose.
The number of patients enrolled in this study will vary between 3 and 24, depending on the clinical findings.
Patients will be treated in 2 centres in London: the BMT unit at Great Ormond Street Hospital (GOSH) and University College London (UCL). Patients will be enrolled over a period of 2 years and their follow-up will continue up to 1 year post BMT.
The results of this study could provide a novel and potentially effective treatment for children with relapsed/refractory leukaemia undergoing BMT.REC name
London - Bloomsbury Research Ethics Committee
REC reference
14/LO/1743
Date of REC Opinion
10 Apr 2015
REC opinion
Further Information Favourable Opinion