Clinical research
At Leukaemia Busters we have always recognized the importance of research that delivers practical benefits for patients. This is so called translational research where a course of research work is designed and conducted with the intent of making practical discoveries. These discoveries can then be translated into clinical practice through the pursuit of clinical trials in patients.
The Simon Flavell Leukaemia Research Laboratory has a good track record in discovering, developing and then testing its own immunotoxin drugs in early phase clinical trials in patients. These early phase trials are designed primarily to determine drug safety and tolerance and secondly efficacy in patients and are undertaken under strictly controlled clinical conditions to ensure the safety and wellbeing of participating patients.
The laboratory has undertaken three major early phase clinical trials in the past in collaboration with the Cancer Research UK (CRUK) Drug Development Office and the United Kingdom Childhood Cancer Study Group (now the Children’s Cancer and Leukaemia Group). They are as follows:
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A two centre (Leeds & Southampton) phase I study of BU12-SAPORIN in adults with relapsed or refractory follicular B-cell lymphoma. This clinical study demonstrated the safety of BU12-SAPORIN in patients treated at the highest dose level used with. A quarter of patients treated showed a response to treatment with BU12-SAPORIN.
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A three centre (Leeds, Manchester and London) phase I study of OKT10-SAPORIN in adults with advanced multiple myeloma. This clinical trial demonstrated the safety of this immunotoxin drug in patients treated up to the highest dose level studied. A number of patients showed clinical improvements following treatment.
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An eleven centre (Southampton, Bristol, Leeds, Liverpool, London, Manchester, Birmingham, Newcastle, Leicester, Sheffield & Cardiff) phase I clinical trial of BU12-SAPORIN in children with multiply relapsed therapy resistant acute lymphoblastic leukaemia. This was the first trial of its type for children with relapsed leukaemia in the UK. These were patients with very advanced disease and a life expectancy of only a few weeks. There were no cures but one Southampton patient unexpectedly survived for 14 months after treatment.
Leukaemia Busters and the laboratory are determined to build on these past successes and take forward its research findings for testing directly in patients in strictly regulated clinical trials. The key to success here is the conduct of high quality laboratory-based research specifically designed to achieve this objective. All donations to Leukaemia Busters are used for this specifically for this very purpose.
