A Trial of De-escalation and Stopping Treatment in Chronic Myeloid Leukaemia Patients With Excellent Responses to Tyrosine Kinase Inhibitor Therapy
The next definitive UK phase III trial in chronic myeloid leukaemia (CML) will be SPIRIT3,
which will open in Summer 2013. This will incorporate a de-escalation and stopping strategy
for patients who achieve excellent responses after at least 3 years of treatment with a
tyrosine kinase inhibitor (TKI).
DESTINY is to act as a pilot for this strategy in SPIRIT3, by defining the proportion of
patients that relapse during 12 months of TKI de-escalation followed by 24 months of
cessation. DESTINY also includes scientific bolt-on studies, quality of life assessments and
health economic evaluation.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• The proportion of patients who can first de-escalate their treatment (to half the standard dose of their TKI) for 12 months, and then stop treatment completely for a further 2 years, without losing MMR.
• The proportion of patients who can first de-escalate their treatment (to half the standard dose of their TKI) for 12 months, and then stop treatment completely for a further 2 years, without losing MMR.
37months
No
Richard E Clark
Principal Investigator
University of Liverpool
United Kingdom: Medicines and Healthcare Products Regulatory Agency
4203
NCT01804985
July 2013
July 2017
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