Establishing prospective Asparaginase activity monitoring

• Research type

  Research Study

• Full title

  Establishing prospective Asparaginase activity monitoring

• IRAS ID

  173370

• Contact name

  Sujith Samarasinghe

• Contact email

  sujith.samarasinghe@gosh.nhs.uk

• Sponsor organisation

  Great Ormond Street Hospital NHS Foundation Trust

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  We wish to establish a validated accredited Asparaginase activity assay within the UK. Asparaginase is a key component of acute lymphoblastic leukaemia (ALL) therapy; however, the production of anti-Asparaginase antibodies in patients can lead to a fall in Asparaginase activity below an effective therapeutic level. Furthermore, such a reduction may occur with no presenting symptoms in the patient. By establishing a technique where by Asparaginase activity can be prospectively monitored, we can ensure patients maintain an adequate level of the drug to achieve the desired anti-leukaemic effect. We aim to develop and optimize such an assay in hospital chemical pathology and enzyme laboratories which will then be validated on clinical samples from a total of 20 patients.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  16/NW/0535

• Date of REC Opinion

  14 Jul 2016

• REC opinion

  Favourable Opinion