The Bloodwise Trials Acceleration Programme (TAP) is growing fast. The network has now opened 12 clinical trials, investigating a wide range of new drugs and treatments for a whole range of blood cancers including acute myeloid leukaemia (AML), chronic lymphocytic leukaemia (CLL) and myelodysplastic syndrome (MDS). Here’s an update on the latest figures, a patient’s perspective and an overview of some of the exciting new trials we have coming up.
Trials accepted into the programme
Number of patients recruited to TAP trials
As you can see, TAP has now recruited over 600 patients and is proving to be a great model for accelerating the delivery of blood cancer trials in the UK.
A patient’s perspective
The first TAP trial to complete its recruitment phase is the IciCLLe trial. This is a clinical trial for a promising new chronic lymphocytic leukaemia (CLL) drug. The trial, run by Prof Pete Hillmen at Leeds’ St James’s University Hospital, looks into ways to enhance the effectiveness of the drug ibrutinib. Below is a testimony from a patient on the IciCLLe trial which describes just what a difference effective treatment can make:
“I was diagnosed with chronic lymphocytic leukaemia in 2007 at the age of 48. Life carried on as normal until 2013, when blood tests showed my platelet count had started to fall. I was monitored for many months and put on a course of steroids, but my platelets continued to drop. Even though I was still working, I felt shattered. I was in hospital for a time with pneumonia.
My specialist told me that it looked like I would have to start on chemotherapy. Just the word ‘chemo’ conjures up pretty frightening images and I searched on to the internet for possible alternatives. I came across the IciCLLe trial at St James’s Hospital in Leeds and arranged to see Professor Hillmen. After speaking to him I felt absolute confidence in his judgement. Tests to find out if I was a suitable candidate for the trial showed that I ticked all the boxes.
After one week of starting on the ibrutinib tablets, the lumps in my neck had nearly gone. It was amazing. Within two weeks, blood tests showed that my white blood cells were down and my platelet count was up. After five or six months on ibrutinib, my platelet count is now virtually normal. It really is a wonder drug."
Along with the 10 trials currently open, we have a number of new and exciting studies which have now also been approved and are due to open over the next 6 months.
Multiple myeloma (MM) is a disease that affects approximately 15-20 per 100,000 people in the Western world. Advances in our understanding of the biology of MM have shown that there are different forms of the disease, because patients have varying genetic abnormalities.
Studies have shown that the drug Bortezomib (Bz) may be effective in improving the outcome of such patients; however, the survival in certain groups is still poorer compared to patients without particular genetic abnormalities. This trial aims to evaluate the combination of BKM-Bz in patients with a specific genetic sub-type of MM, initially to identify a safe dose of BKM-Bz, and then to explore whether this dose is effective in treating patients with MM. Up to 60 patients in the UK will be recruited to this study.
Myeloproliferative neoplasms (MPNs) are uncommon diseases that in some cases will progress to an acute leukaemia which is very difficult to treat. As this often happens to older people, most patients are unsuitable for bone marrow transplant therapy. There are few other treatment options for these patients.
This trial will combine a treatment (ruxolitinib) that is effective at symptom control and may confer a survival advantage in myelofibrosis (an MPN) with azacitidine, a treatment that has proven activity in patients with some types of myelodysplastic syndrome and acute myeloid leukaemia. As these two treatment drugs have not been used together before, the trial will consist of a dose finding component, followed by the recruitment of an additional 10 patients at the maximum dose that is found to be safe and tolerable.
Diffuse large B cell lymphoma (DLBCL) is a relatively treatable condition. However, in some cases the lymphoma can relapse or become resistant to conventional treatment. The protein mTOR has been identified as active in many cancer cell types and is involved in cancer cell growth and survival. Drugs have been made which inhibit this protein. These are effective in many lymphoma subtypes, but only in a minority of patients. One reason may be that current drugs only inhibit part of mTOR function. A new drug, AZD2014, inhibits a wider range of mTOR functions, and so it may work more effectively. AZD2014 is an oral drug taken twice per day. In a previous trial, the safe maximum dose has been established. This study plans to treat patients with DLBCL (the commonest subtype of NHL) at this dose to see how active the drug is in these conditions.
As with all new TAP studies, the aim is for trials to be opened across the network in all centres that have the clinical capacity to run the study. This ensures that a large catchment area of patients is secured and trial recruitment rates are optimal and efficient.