RecruitingNCT06119269

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol


Sponsor

University of Pisa

Enrollment

100 participants

Start Date

Aug 2, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring patients with chronic myeloid leukemia (CML) — a type of blood cancer — who are already taking a drug called ponatinib. Researchers want to understand how the body processes and responds to different doses of this medication over time. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with CML - You are currently taking ponatinib at a dose of 15, 30, or 45 mg per day and have been on it for more than 14 days - You are willing to give informed consent **You may NOT be eligible if...** - You are under 18 years old - You are not willing to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTherapeutic 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)

DIAGNOSTIC_TESTMolecular Response

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


Locations(5)

University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant

Cagliari, Italy

Policlinico Milano

Milan, Italy

University of Naples Federico II - Unit of Hematology

Naples, Italy

Santa Chiara University Hospital

Pisa, Italy

Ospedale S. Eugenio ASL 2 Roma

Roma, Italy

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NCT06119269


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