Major new clinical trial to improve treatment for leukaemia patients

Newcastle researchers will be working with the US pharmaceutical company ARIAD Pharmaceuticals, the UK National Cancer Research Institute and a number of other Universities in one of the largest leukaemia trials ever conducted in the UK.

The trial, called SPIRIT 3, will assess how to select the best treatment for someone with CML and aims to increase the number of patients who respond so well that they can stop drug treatment.

The Newcastle team will be evaluating the performance of a new drug – ponatinib – along with existing medicines imatinib or nilotinib which are already approved by NICE (National Institute for Health and Clinical Excellence) and available on the NHS. Ponatinib is being provided free for the purposes of the trial from ARIAD who are also funding the research.

About 800 people develop CML each year in the UK and there are currently over 6,000 patients with the disease. Symptoms of CML, which are usually picked up by a routine blood test may include tiredness, weight loss, headaches, visual disturbances and abdominal discomfort.
Involving 1,000 patients from more than 150 hospitals across the UK, the SPIRIT 3 trial involves patients being treated for CML in which the granulocyte white blood cells are malignant. White blood cells normally help the body fight infection.
Stephen O’Brien, Professor of Haematology at Newcastle University and a Consultant with The Newcastle Hospitals NHS Foundation Trust who is leading the trial said: “By testing two well-established drugs and a new medicine we are ensuring that patients diagnosed with CML get the most effective treatment allowing them the best quality of life for longer.

“We know existing drugs are effective but they don’t work as well as they might for one in five patients with CML. We need to establish whether we can improve treatment by switching selected patients to ponatinib.”

The SPIRIT 3 study aims, through the collaborative expertise at the universities of Newcastle, Glasgow, Edinburgh, Liverpool, and Imperial College, to uncover the genetic basis of why some people fail to respond to treatment as well as others.

The trial has received approval and been supported by the National Cancer Research Institute (NCRI). This UK-wide partnership between the government, charity and industry promotes co-operation in cancer research for the benefit of patients, the public and the scientific community. The first patients are due to be referred by their cancer specialists to take part in this study in June this year.

Newcastle is in a unique position to co-ordinate the trial with the key partnership between experts from the University and from The Newcastle upon Tyne Hospitals NHS Foundation Trust. They will be using the state of the art clinical facilities provided by the Newcastle Clinical Trials Unit which supports the aim of delivering high quality research to benefit patients.

The trial will support five new jobs including a Consultant, Research Nurse and co-ordinators.

“Working with our industry partner, ARIAD, means patients here in the North East and across the UK, benefit from a faster process to test the benefits of new drugs,” added Professor O’Brien. “It’s an exciting time for all of the team and for patients.”

The outcome of the study will provide evidence for NICE for future decisions on which drugs should be prescribed on the NHS and will help in developing the most cost-effective way to treat CML in the longer term.

In a further innovation the trial tablets will be delivered directly to the homes of patients, the first time this has been done in a UK cancer trial.


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