Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib Previously Treated With 2 or More TKIs

  • STATUS
    Not Recruiting
  • End date
    Jan 15, 2025
  • participants needed
    222
  • sponsor
    Novartis Pharmaceuticals
Updated on 9 June 2021
imatinib
dasatinib
ponatinib
bosutinib
nilotinib
basophils
asciminib

Summary

The purpose of this pivotal study is to compare the efficacy of ABL001 with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs.

Patients intolerant to the most recent TKI therapy must have BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must meet the definition of treatment failure as per the 2013 ELN guidelines.

Patients with documented treatment failure while on bosutinib treatment will have the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.

Details
Condition Chronic myeloid leukemia
Treatment bosutinib, ABL001
Clinical Study IdentifierNCT03106779
SponsorNovartis Pharmaceuticals
Last Modified on9 June 2021

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