Status and phase
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About
The purpose of this study is to investigate whether some patients with excellent responses to chronic myeloid leukaemia (CML) treatment are being overtreated, and can remain well on either a lower dose of treatment or without treatment at all. The dose of imatinib (Glivec), nilotinib (Tasigna) or dasatinib (Sprycel) treatment will initially be cut to half the standard dose for 12 months, and then treatment will be stopped completely for a further two years. The trial information will also help to develop a de-escalation and stopping strategy for future newly diagnosed CML patients in the next British national CML study (to be known as SPIRIT3).
Full description
The next definitive UK phase III trial in chronic myeloid leukaemia (CML) will be SPIRIT3, which will open shortly. 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.
Enrollment
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Volunteers
Inclusion criteria
CML in first chronic phase.
Demonstration of BCR-ABL1 positivity at/shortly after original diagnosis.
Written Informed Consent
Must have received TKI treatment for at least 3 years.
At least 3 molecular results over the preceding 12 months, that fit either of the following groups (results from any UK lab are acceptable):
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
168 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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