Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CML) to Characterize the Efficacy and Safety of a Range of Doses

Official Title

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Summary:

The purpose of this study is to compare and characterize the efficacy and safety of ponatinib in participants with resistant chronic myeloid leukemia (CML) in chronic phase (CP) in a range of doses.

Trial Description

Primary Outcome:

  • Percentage of Participants with ≤1% BCR-ABL 1IS at Month 12
Secondary Outcome:
  • Molecular Response Rates (MRR) at Months 12 and 24
  • Major Cytogenetic Response Rates (MCyR) at Month 12
  • Duration of MRR
  • Percentage of Participants with Arterial Occlusive Events (AOEs) and Venous Thrombotic Events (VTEs), Adverse Events (AEs), and Serious AEs (SAEs)
  • Safety Measured by Comparing Frequencies of AEs, SAEs and VOEs, AOEs and VTEs
  • Analysis of the Relationship Between Steady-state Plasma Ponatinib Exposure [Peak Plasma Concentration (Cmax) and Area-under-the-curve (AUC)] and Safety measures (AOEs and VTEs and any AEs that occur in at least 30 participants)
  • Analysis of the Relationship between Steady-state Plasma Ponatinib Exposure (AUC and Cmax) and Efficacy Measures (including ≤1% BCR-ABL 1IS, MCyR, and MRR
This is a multi-centre, randomized, phase 2 trial to characterize the safety and efficacy of ponatinib over a range of 3 starting doses. Eligible participants must have chronic phase chronic myeloid leukemia (CP-CML) and have demonstrated resistance to treatment or have the T315I mutation.

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