Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Sponsor: University of Pisa
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.
Official title: Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2023-08-02
Completion Date
2025-12-31
Last Updated
2025-06-05
Healthy Volunteers
No
Conditions
Interventions
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 (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