Actively Recruiting
Led by University of Pisa · Updated on 2025-06-05
100
Participants Needed
5
Research Sites
N/A
Total Duration
Researchers are evaluating the relationship between the blood levels of ponatinib and its effects, including both how well it works and its side effects, in patients with chronic myeloid leukemia in the chronic phase (CML-CP). This retrospective observational study aims to understand these associations in patients treated at multiple Italian hematological centers. It also seeks to develop an algorithm to help doctors adjust ponatinib doses based on plasma concentrations, tolerability, and molecular response to treatment. The study involves collecting data from medical records of CML-CP patients who have been treated with ponatinib as a second, third, or fourth line of chemotherapy. Plasma levels of ponatinib measured during routine clinical practice will be analyzed alongside efficacy data, such as molecular response, and records of side effects. Researchers will use statistical and pharmacokinetic modeling to explore factors influencing ponatinib levels and to build a dosing algorithm. Participants' clinical and laboratory data will be anonymized and gathered into a database for analysis. The study will review ponatinib plasma concentrations over two years, along with molecular response and occurrence of adverse events during this period. This approach aims to provide insights from real-life treatment experiences, supporting improved dosing decisions in the future.
CONDITIONS
Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who undergo routine care are observed. Plasma concentrations of ponatinib and molecular response levels are measured to assess treatment efficacy and safety.
Regular assessments during routine clinical visits
Total: 5 locations
1
University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant
Cagliari, Italy, 09124
Actively Recruiting
2
Policlinico Milano
Milan, Italy, 20122
Actively Recruiting
3
University of Naples Federico II - Unit of Hematology
Naples, Italy, 80131
Actively Recruiting
4
Santa Chiara University Hospital
Pisa, Italy, 56126
Actively Recruiting
5
Ospedale S. Eugenio ASL 2 Roma
Roma, Italy, 00144
Actively Recruiting
S
Sara Galimberti, PhD
C
Claudia Baratè, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Sara Galimberti, Elisabetta Abruzzese, Giacomo Luci...
https://pubmed.ncbi.nlm.nih.gov/38543276