Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
NCT ID: NCT06119269
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-08-02
2025-12-31
Brief Summary
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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.
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Detailed Description
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Classical statistical analyses (for descriptive and comparison aims) will be used according to their appropriateness. Moreover, factors affecting the pharmacokinetics (PK) of ponatinib will be investigated by nonlinear mixed effect modeling adopting the MONOLIX 2021R2 suite. Final model will be used as parte of the dosing algorithm.
Notably, all clinical and laboratory data will be anonymized to protect patients' privacy, and harvested in a database that will be used to perform pharmacometric and statistical analyses.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patients who did not provide an informed consent to the study
The co-administration of drugs other than ponatinib will not be considered an exclusion criterium, but all of the drugs will be registered (together with daily doses and duration of treatment) as possible factors of ponatinib PK variability.
18 Years
ALL
No
Sponsors
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University of Pisa
OTHER
Responsible Party
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Antonello Di Paolo, M.D., Ph.D.
Professor of Pharmacology
Principal Investigators
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Sara Galimberti, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pisa - Dept. Clinical and Experimental Medicine
Locations
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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
Napoli, , Italy
Santa Chiara University Hospital
Pisa, , Italy
Ospedale S. Eugenio ASL 2 Roma
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Galimberti S, Abruzzese E, Luci G, Barate C, Luciano L, Iurlo A, Caocci G, Morganti R, Stefanelli F, Di Paolo A. A New Algorithm Integrating Molecular Response, Toxicity, and Plasma Level Measures for Ponatinib Dose Choice in Patients Affected by Chronic Myeloid Leukemia. Pharmaceutics. 2024 Mar 11;16(3):383. doi: 10.3390/pharmaceutics16030383.
Other Identifiers
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23707
Identifier Type: -
Identifier Source: org_study_id
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