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Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

NCT06119269 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-06-05

No results posted yet for this 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.

Conditions

  • Chronic Myeloid Leukemia, Chronic Phase

Interventions

DIAGNOSTIC_TEST

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)

DIAGNOSTIC_TEST

Molecular Response

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

Sponsors & Collaborators

  • University of Pisa

    lead OTHER

Principal Investigators

  • Sara Galimberti, PhD · University of Pisa - Dept. Clinical and Experimental Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119269 on ClinicalTrials.gov