Evaluating ponatinib treatment in chronic myeloid leukemia patients
Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol
This study is testing how well the drug ponatinib works and how safe it is for people with chronic myeloid leukemia who are on their second, third, or fourth round of treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Drugs / interventions | ponatinib, chemotherapy |
| Locations | 5 sites (Cagliari and 4 other locations) |
| Trial ID | NCT06119269 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic myeloid leukemia who have been treated with ponatinib for more than 14 days.
Not a fit: Patients under 18 years old or those who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing strategies for ponatinib, enhancing treatment efficacy and reducing toxicity for patients with chronic myeloid leukemia.
How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown promise in optimizing treatment through therapeutic drug monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cagliari and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.