Evaluating ponatinib treatment in chronic myeloid leukemia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the relationship between plasma concentrations of ponatinib and its efficacy and tolerability in patients with chronic myeloid leukemia in chronic phase. It will collect data from medical records across several Italian hematological centers, focusing on patients treated with ponatinib as a second, third, or fourth line of chemotherapy. The study will also develop an algorithm to assist physicians in optimizing drug dosing based on plasma concentrations and patient responses. Statistical analyses will be performed to correlate drug levels with treatment outcomes and adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant
  Cagliari, Italy Recruiting
• Policlinico Milano
  Milan, Italy Recruiting
• University of Naples Federico II - Unit of Hematology
  Naples, Italy Recruiting
• Santa Chiara University Hospital
  Pisa, Italy Recruiting
• Ospedale S. Eugenio ASL 2 Roma
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Sara Galimberti, PhD — University of Pisa - Dept. Clinical and Experimental Medicine
• Study coordinator: Sara Galimberti, PhD
• Email: sara.galimberti@unipi.it
• Phone: +39 050 993111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.