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Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

ConditionChronic Myeloid Leukemia, Chronic Phase
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pisa

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects ≥18 years old affected by CML

Patients being treated with ponatinib at a dose of 45, 30 or 15 mg/day for more than 14 days

Patients who have provided informed consent to the study

Disqualifiers

Subjects <18 years old

Patients who did not provide an informed consent to the study

Trial population

Patients diagnosed with CML-CP who received ponatinib as 2nd-4th chemotherapy line will be enrolled according to inclusion/exclusion criteria listed.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Therapeutic drug monitoring

    Diagnostic test

    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

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Ponatinib plasma concentrations

Plasma concentrations of ponatinib included in the therapeutic range (i.e., \>21 nM)

Time frame
2 year

Secondary outcomes

1

Molecular response

Plasma levels of BCR-ABl transcript

Time frame
Up to 2 year
2

Occurrence of adverse events/adverse drug reactions

Adverse events/Adverse drug reactions observed and registered during ponatinib administration

Time frame
Up to 2 year

Other outcomes

Sponsors and contacts

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University of Pisa

Lead sponsor

Source ClinicalTrials.gov
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