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A single arm phase II study to individualize dasatinib dosing based on trough levels and molecular response to maintain efficacy whilst minimising toxicity

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Trial Profile

A single arm phase II study to individualize dasatinib dosing based on trough levels and molecular response to maintain efficacy whilst minimising toxicity

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Apr 2022

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At a glance

  • Drugs Dasatinib (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Adverse reactions
  • Acronyms DIRECT

    • Most Recent Events

    • 06 Nov 2019 According to an interim analysis results, released in the 61st Annual Meeting and Exposition of the American Society of Hematology, this trial initially only enrolled patients greater than 60 years old, predicted to derive the greatest potential benefit from a reduction in toxicity. The protocol was amended after 34 pts were accrued to include patients greater than 18 years old at the recommendation of the trial management committee.
    • 06 Nov 2019 Results of a per-protocol interim analysis (n=71, as of Jun 2019) based on early molecular response and MMR at 12 months, both key secondary endpoints of the study, were released in the 61st Annual Meeting and Exposition of the American Society of Hematology.
    • 13 Aug 2019 Status changed from recruiting to active, no longer recruiting.

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