The first of these is CLARITY, which is looking at a new drug combination to treat chronic lymphocytic leukaemia. The second new trial to open is the BUBBLE trial, focusing on multiple myeloma.
Bloodwise's early phase Trials Acceleration Programme (TAP) has progressed from a pilot to a full programme and been funded for a further 5 years until 2020. TAP aims to boost the number and speed of early stage clinical trials, testing promising new treatments and diagnostics. These types of trials usually focus on testing how safe a treatment is, what side effects might occur, what the best dose and schedule is, whether there are signs it can work against the disease and which patients might benefit most. It's a crucial link between the discoveries made in the lab and the new treatments patients receive.
This long-term investment into clinical trials will continue to resource a specialised TAP Hub in Birmingham and 13 networked recruitment centres in leading research hospitals around the UK. To date, the programme has opened 17 trials with over 750 patients taking part.
In the past two weeks, two new trials have opened to recruitment across the TAP network. The first of these is CLARITY, which is looking at a new drug combination to treat chronic lymphocytic leukaemia (CLL). CLL is the most commonly diagnosed leukaemia in the western world. Some patients with CLL never need treatment and live a relatively normal life, but many become unwell and die prematurely from the disease. At the moment, stem cell transplantation is the only proven cure for CLL but this is not always possible. Many treatments to control the disease involve chemotherapy which, although it can be effective, can also have serious side effects. This is especially problematic for older people, who tend to be frailer and suffer other health problems at the same time. Many patients do ultimately relapse and become resistant to treatment.
The drug ibrutinib is a major recent advance in CLL treatment and has shown promise in achieving good results in trials across a range of patients. Ibrutinib, however, does have limitations - although it brings initial positive effects, few patients achieve complete, durable remission. This new trial, led by Professor Peter Hillmen at St James's Hospital Leeds, aims to increase the effectiveness of ibrutinib by using it in combination with another promising drug, Venetoclax. Venetoclax is a new small molecule oral drug that is currently being tested on patients with relapsed, treatment-resistant CLL and is also producing some encouraging results. This trial builds on several other TAP CLL trials (IciCLLe & IciCLLe 2) and the results on the safety and effectiveness of this new combination will be used to inform the design of larger, practice-changing phase III trials in newly diagnosed CLL patients.
The second new TAP trial to open is the BUBBLE trial. Advances in our understanding of the biology of multiple myeloma (MM) have shown that patients have varying genetic abnormalities related to the disease and this represents a major challenge in the development of new treatments. Attempts to improve outcomes in certain patients with a "high risk myeloma" profile have up to now failed to tackle these different disease mechanisms. Professor Kwee Yong’s research group from University College London have identified a new class of drugs that could play a crucial role in targeting specific high risk sub-types of MM. One such drug is BKM120 (BKM), which has shown to be effective in patients with other blood cancers. This new trial aims to evaluate the combination of BKM with another drug, Bortezomib (Bz), in patients with MM who have a particular genetic profile. This the first trial of its kind to first genetically identify MM patients and then treat accordingly. The success of this approach relies not only on the performance of the drugs but also on robust lab analysis to select the right patients. Up to 60 patients in the UK will be recruited to this study and the researchers aim to firstly identify a safe dose of BKM-Bz and then explore whether this dose is effective in treating the selected patients.
For more information on either of these trials, please contact Emil Kazounis – Bloodwise Trials Acceleration Programme Manager.