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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06119269
Other study ID # 23707
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2, 2023
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source University of Pisa
Contact Sara Galimberti, PhD
Phone +39 050 993111
Email sara.galimberti@unipi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The study protocol is a non-interventional, retrospective observational study which involves the collection of data from medical records relating to the plasma dosages of ponatinib performed as per clinical practice, all carried out at the pharmacokinetics laboratory of the U.O. Clinical Pharmacology and Pharmacogenetics of AOUP. These data will be collected in CRF and will be correlated to efficacy data (extent of molecular response) and toxicity of ponatinib (haematological, extra-haematological adverse events, together with adverse event severity). Real-life experience (dosage adjustments made by clinicians based on plasma dosage) will be used to propose an algorithm that can help in choosing the correct dosage of ponatinib. Classical statistical analyses (for descriptive and comparison aims) will be used according to their appropriateness. Moreover, factors affecting the pharmacokinetics 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Patients will be enrolled according the following inclusion criteria: - 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 Exclusion criteria: - Subjects <18 years old - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant Cagliari
Italy Policlinico Milano Milano
Italy University of Naples Federico II - Unit of Hematology Napoli
Italy Santa Chiara University Hospital Pisa
Italy Ospedale S. Eugenio ASL 2 Roma Roma

Sponsors (1)

Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ponatinib plasma concentrations Plasma concentrations of ponatinib included in the therapeutic range (i.e., >21 nM) 2 year
Secondary Molecular response Plasma levels of BCR-ABl transcript Up to 2 year
Secondary Occurrence of adverse events/adverse drug reactions Adverse events/Adverse drug reactions observed and registered during ponatinib administration Up to 2 year
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