Actively Recruiting
Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Led by University of Pisa · Updated on 2025-06-05
100
Participants Needed
5
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects 6 years old affected by chronic myeloid leukemia
- Patients treated with ponatinib at doses of 45, 30, or 15 mg/day for more than 14 days
- Patients who have given informed consent to participate in the study
You will not qualify if you...
- Subjects under 18 years old
- Patients who have not given informed consent to participate in the study
AI-Screening
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Trial Site Locations
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
Research Team
S
Sara Galimberti, PhD
CONTACT
C
Claudia Baratè, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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