Clinical trial · Observational
Retrospective Evaluation of CML Patients in the National Compassionate Program
Ponatinib Survey: Retrospective Evaluation of CML Patients in the National Compassionate Program According to the 648/96 Decree
NCT02448095CI-TRIAL-00061713terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of interest
Summary
Brief summary (as posted)
This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.
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 |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Philadelphia Positive | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ponatinib | Drug | Ponatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- CML ph+ patients
- description
- Chronic myeloid leukemia patients who are philadelphia positive
- interventionNames
- Drug: Ponatinib
Primary outcomes (1)
- measure
- Number of adverse events
- timeFrame
- Maximum of 60 months from treatment start
- description
- General adverse events and grade 3-4 adverse events according to NCI CTCAE version 4.0
Secondary outcomes (7)
- measure
- Number of patients with hematological complete response
- timeFrame
- Maximum of 60 months from treatment start
- description
- Hematological complete response and related responses, such as major cytogenetic response, complete cytogenetic response and major molecular response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CML Ph+ patients in chronic phase * 18 years old or older * Patients have received either Dasatinib or Nilotinib and resulted resistant or not tolerant to the drugs or have developed the T3151 mutation * Patients have started Ponatinib at least 12 months before registration * Informed consent signed at registration Exclusion Criteria: * CML Ph+ patients in accelerated or blast phase with acute lymphoblastic leukemia
References
Publications (0)
Data not yet available
No reference posted for this study.