Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant
RECRUITING
Cagliari
Policlinico Milano
RECRUITING
Milan
University of Naples Federico II - Unit of Hematology
RECRUITING
Napoli
Santa Chiara University Hospital
RECRUITING
Pisa
Ospedale S. Eugenio ASL 2 Roma
RECRUITING
Roma
Contact Information
Primary
Sara Galimberti, PhD
sara.galimberti@unipi.it
+39 050 993111
Backup
Claudia Baratè, MD
claudia.barate@gmail.com
+39 050 992111
Time Frame
Start Date: 2023-08-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Sponsors
Leads: University of Pisa

This content was sourced from clinicaltrials.gov

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