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 with BCR-ABL ratios ≥ 1% IS at screening.

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