Clinical trial · Observational
Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase
Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia, Chronic Phase | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular Response | Diagnostic Test | — | UNRESOLVED |
| Therapeutic drug monitoring | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Ponatinib plasma concentrations
- timeFrame
- 2 year
- description
- Plasma concentrations of ponatinib included in the therapeutic range (i.e., \>21 nM)
Secondary outcomes (2)
- measure
- Molecular response
- timeFrame
- Up to 2 year
- description
- Plasma levels of BCR-ABl transcript
- measure
- Occurrence of adverse events/adverse drug reactions
- timeFrame
- Up to 2 year
- description
- Adverse events/Adverse drug reactions observed and registered during ponatinib administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTGalimberti S, Abruzzese E, Luci G, Barate C, Luciano L, Iurlo A, Caocci G, Morganti R, Stefanelli F, Di Paolo A. A New Algorithm Integrating Molecular Response, Toxicity, and Plasma Level Measures for Ponatinib Dose Choice in Patients Affected by Chronic Myeloid Leukemia. Pharmaceutics. 2024 Mar 11;16(3):383. doi: 10.3390/pharmaceutics16030383. PMID 38543276