The Trials Acceleration Programme (TAP)
09 Dec 2020
Led from Birmingham, The Trials Acceleration Programme (TAP) is now opening across its network VICTOR, a phase II trial of adults with acute myeloid leukaemia with a NPM1 mutated FLT3 negative genotype. Patients are randomised 1:1 to receive intensive chemotherapy (daunorubicin, cytarabine and gemtuzumab ozogamicin) or venetoclax and low dose cytarabine. Current standard of care for these patients is intensive chemotherapy, although this is associated with high remission rates of 60-80% it is associated with high toxicity and treatment related mortality causing death in 5-10% of younger and approximately 20% of older patients.
Recent phase I studies have shown that combining venetoclax with low dose cytarabine has been effective in producing high remission rates comparable to intensive chemotherapy, with fewer side effects and treatment related mortality in patients who are not fit to receive intensive chemotherapy. Therefore the VICTOR trial will be the first trial to compare this combination to intensive chemotherapy in patients who are eligible to receive intensive chemotherapy. The trial aims to recruit 156 patients aged ≥60 years over 2 years from the UK, Denmark and New Zealand. If non-inferiority in the venetoclax + low dose cytarabine is demonstrated, up to 30 additional patients aged 50-59 years may be recruited in a parallel cohort to the ≥60 cohort. Patients will be followed up for 2 years.
The TAP programme is also about to open PROMise, with plans to recruit at 16 sites across the UK. This phase I trial combines a new BET inhibitor (PLX2853) with ruxolitinib and is for patients with intermediate-2 or high risk myelofibrosis who are not currently receiving an adequate response with ruxolitinib alone. The main aims of the study are to find a suitable recommended phase 2 dose of PLX2853 when combined with ruxolitinib, to investigate the safety by looking at the side effects of treatment and to see if the combination provides a clinical benefit to patients with myelofibrosis. The study Chief Investigator is Professor Adam Mead of John Radcliffe Hospital, Oxford. Find out more
Find out more about the TAP programme