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Blood cancer trial sponsored by the University of Birmingham opens for recruitment

A new Cancer Research UK-funded clinical trial being sponsored by BHP founder-member the University of Birmingham has opened for recruitment – aiming to investigate the efficacy of a novel treatment for patients affected by a specific type of blood cancer.

PROMise, which is being co-ordinated via the Cure Leukaemia-funded Trials Acceleration Programme (TAP) hub at the University of Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU), will recruit patients aged over 16 who suffer with myelofibrosis (MF).

Over the next two years, 15 NHS centres will recruit MF patients who will be given a novel agent called PLX2853 in addition to the existing standard treatment of ruxolitinib.

Each year in the UK over 300 patients are diagnosed with MF, which is a blood cancer associated with debilitating symptoms including extreme fatigue, pain, weakness and shortness of breath. Around 10-20% of MF patients go on to develop acute myeloid leukaemia (AML) and consequently, a diagnosis of MF has a huge impact on both length and quality of life, with median survival from the time of diagnosis being just two years for patients with high-risk disease.

The only curative therapy for MF is stem cell transplant; however, this is only suitable for a small minority of younger patients who don’t present with comorbidities (the effect of all other conditions an individual patient might have – physiological or psychological).

The current NHS standard of care for those unsuitable for stem cell transplant is treatment with ruxolitinib, approved for use in 2011 and currently the only therapy approved with an indication for MF.

Professor Pam Kearns, Director of the University of Birmingham’s CRCTU, said: “Whilst ruxolitinib is already in widespread clinical use, many patients do not achieve an adequate response. Significant residual symptoms remain in most patients thus there is a major unmet clinical need and the PROMise trial is addressing an urgent need for improved therapeutic approaches for MF patients.”

Chief Investigator, Professor of Haematology at University of Oxford, Adam Mead, said: “The PROMise study is a really exciting study that has just opened in the UK and will be opening across 15 centres. This is introducing a new treatment called PLX2853, in combination with ruxolitinib, for patients with MF. The impact on patients for this combination of treatments, I hope, will be improvement of their symptoms, improvement of their quality of life, without causing them side effects.”