The UK’s King’s College Hospital NHS Foundation Trust has announced the first global patient recruitment for TAK-226-3001, a Takeda Pharmaceuticals’ Phase III trial assessing elritercept against epoetin alfa for anaemia in adults with a rare type of blood cancer.
The study involves patients with very low, low or intermediate risk myelodysplastic syndromes (MDS) who require regular red blood transfusions.
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It aims to enrol 300 participants, who may remain in the study for up to five years. King’s is one of only two UK hospitals taking part.
Researchers want to establish whether elritercept reduces the need for red blood cell transfusions, and how its safety compares with epoetin alfa.
Additional objectives include assessing fatigue reported by participants, transfusion burden, quality of life and the extent of the immune response to the therapy.
MDS is described as a pre-leukaemia disorder. Patients face a raised risk of progression to leukaemia and commonly develop anaemia, which affects their quality of life.
King’s consultant haematologist and study chief investigator Dr Austin Kulasekararaj said: “King’s College Hospital is a National Reference Centre for MDS, and patients are referred to us for cutting-edge clinical trials to improve their outcomes and quality of life.
“The only approved treatment in the UK for ‘lower risk’ MDS is supportive treatment with erythropoietin (natural hormone) injections, and if this fails, patients start needing blood transfusions. This trial could provide a fantastic opportunity for our patients to benefit from this therapy.”
The National Institute for Health and Care Research (NIHR) Clinical Research Facility at King’s supported the recruitment, which took place ahead of national targets set by the government in April.
These targets are intended to cut the time needed to set up clinical trials in the UK.
King’s College Hospital NHS Foundation Trust runs more than 1,200 active studies annually, covering discovery science, translational research, clinical trials, data-enabled research and population health.
Its research units include the Cicely Saunders Institute, the Clinical Age Research Unit, the Harris Birthright Centre and the HIV Research Centre.