PROMise Trial Opens

27th May 2021


The Cure Leukaemia-funded Trials Acceleration Programme (TAP) has launched PROMise, a new clinical trial offering a novel treatment option for patients with myelofibrosis (MF).  PROMise, co-ordinated via the TAP hub at the Cancer Research UK Clinical Trials Unit (CRCTU) and sponsored by the University of Birmingham, opened recently at University Hospital of Wales in Cardiff and Nottingham University Hospital.  Along with 13 other NHS centres, University Hospital of Wales and Nottingham University Hospital will recruit MF patients over the next 2 years, providing them with the opportunity to take part in a trial that offers a promising alternative to the current standard of care.

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 just 2 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 ruxolitnib, approved for use in 2011 and currently the only therapy approved with an indication for MF. Ruxolitinib is already in widespread clinical use, however many patients do not achieve an adequate response. Significant residual symptoms remain in most patients thus there is a major unmet need for MF patients who do not achieve an adequate response to ruxolitinib and an improvement in therapeutic approaches for MF patients is urgently needed.

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 ruxolitininb, 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.”

 

PROMise is a phase 1 clinical trial which offers new hope to patients, aged 16 or over, suffering with the debilitating symptoms of MF, by adding novel agent PLX2853 to the existing standard of care. PROMise aims to:

  • establish the dose of PLX2853, administered in combination with ruxolitinib, that is tolerable
  • assess the efficacy of the combination of PLX2853 and ruxolitinib for reduction of symptoms associated with MF
  • assess the safety of the combination of PLX2853 and ruxolitinib

Up to 60 patients will take part in PROMise, which will open at 15 NHS centres across the UK. PROMise is delivered by TAP and sponsored by The University of Birmingham.  CRUK provide trial funding and Plexxicon provide financial support as well as free of charge investigational product PLX2853.

Professor Adam Mead, said: “The funding from Cure Leukaemia is really important for the day-to-day running of this study as Cure Leukaemia are providing nursing support in each of the centres.”

CEO of Cure Leukaemia, James McLaughlin said:

 

“It is fitting to announce this news on World Blood Cancer Day as PROMise is another example of a pioneering blood cancer clinical trial that is now running in the UK thanks to TAP.

 

“Without Cure Leukaemia’s funds, this study would not be currently recruiting patients and giving them access to potentially life-changing treatment. This highlights why this network is so vital and why funds raised for Cure Leukaemia make a direct impact on the lives of the 38,000 people diagnosed with a form of blood cancer in the UK each year.”

Patients wishing to take part in this study should speak directly to their consultant.

This trial is running in the UK thanks to the national Trials Acceleration Programme (TAP) which is solely funded by Cure Leukaemia. To ensure more trials like this can be opened across the UK please show your support by clicking HERE.

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"Cure Leukaemia’s funding of the UK Trials Acceleration Programme (TAP) is a game-changer and increases the access for blood cancer patients to potentially transformative new therapies."

Sir John Bell
"Cure Leukaemia’s funding of the UK Trials Acceleration Programme (TAP) is a game-changer and increases the access for blood cancer patients to potentially transformative new therapies."

Sir John Bell