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Bloodwise clinical trial looks at ways to improve the use of new leukaemia drug

The Bloodwise logo. Bloodwise appears in black text against a white background
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30 Aug 2016

The Trials Acceleration Programme (TAP) trial, which has finished recruiting patients, is informing doctors of ways to enhance the effectiveness of ibrutinib.

A promising new drug is benefiting patients with the blood cancer chronic lymphocytic leukaemia (CLL) – the most common form of leukaemia – according to early findings from a nationwide clinical trial run by doctors at Leeds’ St James’s University Hospital.

The trial is informing doctors of ways to enhance the effectiveness of ibrutinib, which was added to the Cancer Drugs Fund in 2015. Ibrutinib is taken in tablet form and has been shown to extend survival in patients who stop responding to traditional chemotherapy, with limited side-effects.

Ibrutinib works by disabling an enzyme in leukaemia cells vital to their growth and survival, called ‘Bruton’s tyrosine kinase’. However, little is known about how the drug interacts with the tissues surrounding the cancer cells - the bone marrow and lymph nodes. Researchers believe that understanding this and knowing which other drugs to add to the treatment could be key to enhancing ibrutinib’s effectiveness.    

The clinical trial, which has recently finished recruitment of 40 patients, is being funded by Bloodwise. It has taken place at eight UK hospitals involved in the blood cancer charity’s Trials Acceleration Programme (TAP) network – a national collaboration to boost the number and speed of blood cancer clinical trials.  

Professor Peter Hillmen, who is leading the trial at St James’s University Hospital, said: “This trial gives us a unique insight into the exact mechanism by which ibrutinib works. It is vital to maximise the benefits of targeted drugs for patients with CLL. Finding the right combinations will help us to remove the need for chemotherapy, moving us to more effective treatments or even cure as soon as possible.

“The TAP network provides the research community in the UK with a unique opportunity to rapidly improve blood cancer treatment, as well as providing patients with access to many new effective drugs. The programme maintains the UK’s position at the forefront of research into blood cancers.”

Previously untreated patients and patients who have relapsed or failed to respond to traditional treatment took part in the clinical trial. The researchers are examining how to use ibrutinib safely and effectively in combination with other drugs to treat this common form of blood cancer.

Circulating leukaemia cells in the blood, bone marrow and tissue, and biological response to treatment are frequently monitored in patients. A technique called flow cytometry is giving insights into how ibrutinib shifts the crucial balance between cancer cell growth and death in the blood.  

Dr Matt Kaiser, Head of Research at Bloodwise, said: “Ibrutinib is likely to fundamentally change the way we treat chronic lymphocytic leukaemia, so it is crucial that we fully understand how it works. This trial has allowed many patients in need of treatment to receive this exciting new drug before it is widely available.”

Elizabeth's story

Elizabeth was diagnosed with chronic lymphocytic leukaemia in 2010. When conventional treatment failed, her doctors put her forward for the Bloodwise clinical trial in December 2014. She responded well to the drug and she’s in now part of an extension to the trial, which combines an additional drug with the original one.

“I went to the GP in 2009 after I’d been constantly tired for a while and my lymph nodes were swollen. I was diagnosed with chronic lymphocytic leukaemia following blood tests.

To begin with no treatment was necessary, but in 2010 my white cell count had increased to the extent that I needed to start chemotherapy. In 2011 I had a stem cell transplant. This was successful, though the recovery took some months.   I was quite well until January 2014, when I began to get repeated infections and my haemoglobin levels began to drop.  By November, I needed to have a blood transfusion every week. My energy levels were incredibly low and I was feeling unwell all the time.

Despite the success of the stem cell transplant, the disease had recurred. The previous chemotherapy had clearly not eradicated all the CLL cells. My doctors got in touch with the team at the St James’s Hospital in Leeds to discuss treatment options. Ibrutinib was one of a new type of drug targeting CLL cells specifically and fortunately I was eligible for the trial.

I started on the trial in December and the impact was fairly dramatic. I had no further need for blood transfusions one week after starting the treatment. I was able to start playing golf again and I’ve been much more active. We even managed to go on holiday, which wouldn’t have been possible before I started on the trial. 

I did have an infection in June 2015 and had to stop the drug for a few weeks, and immediately required a blood transfusion. Since resuming Ibrutinib I have been fine with no further problems. I had to go down to Leeds fairly frequently to start with to be monitored as part of the trial, but now it’s just once every three months for a check-up and tests.

In February 2016 I started on an extension to the trial with Professor Hillmen’s group, which adds another drug called obinutuzumab to the ibrutinib trial. The results are very encouraging - the levels of CLL in my bone marrow have dropped even further.

The major benefit has been that I am no longer transfusion dependent. I am able lead a normal life, gardening, playing golf and going on holiday. Had I not gone on this trial, more chemotherapy could perhaps have been an option, but that had not been successful in stopping the progression of the cancer in the past. The clinical trial has had a real impact on my quality of life.”