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

Official Title

A Phase 3, Multi-centre, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

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.

Trial Description

Primary Outcome:

  • Major Molecular Response (MMR) rate
Secondary Outcome:
  • Major Molecular Response (MMR) rate
  • Complete Cytogenetic response rate
  • Time to MMR
  • Duration of MMR
  • Time to CCyR
  • Duration of CCyR
  • Time to treatment failure
  • Progression free survival
  • Overall survival
  • Trough plasma concentrations
  • PK parameter: Cmax,
  • PK parameter: Tmax
  • PK parameter: AUC0-12h
  • PK parameter: CL/F

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society