PRIMAL
Research type
Research Study
Full title
Feasibility of early prediction of response to cytarabine in Acute Myeloid Leukaemia patients( AML) to potentially individualise further chemotherapy
IRAS ID
194417
Contact name
Priyanka Mehta
Contact email
Sponsor organisation
University hospitals Bristol NHS Foundation trust
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
This study aims to determine the feasibility of the processes involved in recruiting, consenting and the taking and processing of blood samples from patients with acute myeloid leukaemia. It will use patented but non CE marked equipment. Despite advances in the treatment of childhood leukaemia,adult leukaemia still represents a considerable clinical challenge. The average age of leukaemia in adults is 65 years with those >70 years classified as elderly. Once diagnosed the decision to treat is rapid, as life expectancy for the patient is a few months without treatment. For a large number of elderly patients, intensive chemotherapy is not an option due to poor physical fitness and co-morbidities. Increasingly clinicians are opting to give elderly patients lowdose chemotherapy, controlling their disease whilst minimising side effects, however the chances of acheiving long term survival with low intensity chemotherapy is <20%. The decision to treat or not is currently made using factors such as patient age, performance status and co-morbidities. We have developed an assay capable of detecting the level of sensitivity of leukaemia to chemotherapy in patients prior to treatment. This information could assist the clinician in the decision to treat an
elderly patient with chemotherapy and the assay is being evaluated as a pre-treatment prediction tool. However this assay additionally can monitor levels of the chemotherapy inside the patient’s tumour cells over the first days of treatment, as well as monitoring circulating levels levels of the pro-drug form in patient blood. Assessment of tumour burden over this short time period has previously been shown to predict patient response to the first course of treatment. This information coupled to the response of the tumour cells to the treatment using our assay, this could provide greater information to clinician and patient during the crucial few days after
treatment commences.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
15/WM/0415
Date of REC Opinion
25 Nov 2015
REC opinion
Favourable Opinion