Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

Condition(s) studied

Investigational drug(s) / intervention(s)

Therapeutic drug monitoring: At each follow up visit, plasma concentrations of ponatinib will be measured and compared with therapeutic range (according to a lower concentration equal to 21 nM)

Molecular Response: BCR-ABl transcript levels will be assessed to evaluate molecular response to ponatinib

Study summary

The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy/tolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP).

In particular, the aims of the study will be:

* primary aim: to investigate the relationships (if any) between plasma concentrations and activity/toxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers;
* secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy).

The study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.

Eligibility

Primary outcome measure(s)

• Ponatinib plasma concentrations — 2 year
  Plasma concentrations of ponatinib included in the therapeutic range (i.e., \>21 nM)

Trial sites (5)

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