Clinical trial · Observational
Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-world
Retrospective, Observational, Study on the Evaluation of the Real-world Outcome of Philadelphia-positive Acute Lymphoblastic Leukaemia Patients Treated With Ponatinib as First-line Treatment Under the Italian Law 648/96 (PONA4ALL Ph+)
- 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 learn about the efficacy of ponatinib in Philadelphia-positive ALL (Ph+ ALL) patients in a real-world setting. The main goal of the study is to assess the rate of complete molecular response (CMR) induced by ponatinib in patients treated under the regulations of Law 648/96, outside clinical trials. Patients who were treated with ponatinib as part of their regular medical care and completed the follow-up period will be included in the study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphobkastic Leukemia | — | UNRESOLVED | — |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients treated with ponatinib in first line
- description
- Patients treated with ponatinib as first line, alone or in combination with other antileukaemic agents, under Law 648/96.
Primary outcomes (1)
- measure
- Efficacy of ponatinib in terms of complete molecular response (CMR) achievement
- timeFrame
- 3 months
- description
- Rate of patients treated with ponatinb in first-line who achieve complete molecular response (CMR) after induction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is \> 18 years old; 2. Patient was treated in first-line with ponatinib monotherapy or in association with chemotherapy or immunotherapy; 3. Patient received ponatinib under the regulations of Law 648/96; 4. \- Patient is alive and have at least 18 months of retrospective observation available from the start of ponatinib treatment, OR \- has died/lost to follow-up at any time after treatment initiation, regardless of the length of available follow-up; 5. Signed informed consent, if applicable. Exclusion Criteria: * None
References
Publications (0)
Data not yet available