DESTINY

• Research type

  Research Study

• Full title

  A trial of de-escalation and stopping treatment in chronic myeloid leukaemia patients with excellent responses to tyrosine kinase inhibitor therapy DESTINY(De- Escalation and Stopping Treatment of Imatinib, Nilotinib or sprYcel in chronic myeloid leukaemia)

• IRAS ID

  113787

• Contact name

  Clark Richard

• Contact email

  clarkre@liverpool.ac.uk

• Eudract number

  2012-004025-24

• Clinicaltrials.gov Identifier

  NCT01804985

• Research summary

  Chronic myeloid leukaemia (CML) is a malignant disease of the bone marrow that has a tendency to transform to acute leukaemia, and once this occurs the outlook is grave. However, CML treatment has been completely transformed in the last decade by the advent of the tyrosine kinase inhibitor (TKI) drugs imatinib, dasatinib and nilotinib. After some years of TKI treatment, sensitive (PCR based) blood tests can no longer detect CML in some patients; these are termed complete molecular responders or ’MR4’ responders. In others, the CML is only detectable at very low levels; these are major molecular responders (MMR). MR4 and MMR patients have a very low risk of progressing to acute leukaemia, but still have side effects of treatment. MR4 and MMR patients may therefore be unintentionally overtreated.
  In this trial (called DESTINY), we will study decreasing/stopping TKI treatment in CML patients who have been treated by TKI for some years and are in MR4 or MMR. To minimise relapse, treatment will first decrease by 50% for 12 months, to screen out patients whose leukaemia is ‘only just’ below the MR4 or MMR level, and for whom completely stopping treatment might be unwise. Those patients whose leukaemia remains under excellent control after 12 months will then stop treatment completely. Regular monitoring will be done throughout.
  DESTINY will be run by an experienced multi-site team, including patient advisors. Feedback from CML patients at recent national meetings indicates enthusiasm for the study. Assessment will include quality of life, health economics and relapse rate. Associated scientific studies will investigate why certain patients relapse. The results will help us decide whether decreasing and stopping treatment is safe and cost-effective for the increasing number of CML patients with excellent control.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  13/NW/0265

• Date of REC Opinion

  20 May 2013

• REC opinion

  Further Information Favourable Opinion