Clinical trial · Observational
Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose
NCT03933852CI-TRIAL-00066301PonderosaunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Additional information is needed to characterize the safety profile of ponatinib as it is used in routine clinical practice in Europe. This observational cohort study will provide a real-life picture of ponatinib use in clinical practice and additional quantification and characterization of adverse events (AEs) and their outcomes in patients with Chronic Myeloid Leukemia in any phase treated with ponatinib.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Change in Cytogenetic response
- timeFrame
- through study completion, an average of 3 years
- description
- Achievement of cytogenetic Response (percentage of Ph+ metaphases)
- measure
- Molecular response
- timeFrame
- through study completion, an average of 3 year
- description
- BCR-ABL in % (lower is better)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (age ≥18 years) with Chronic Myeloid Leukemia in any phase who are initiating ponatinib monotherapy, or for whom ponatinib monotherapy was initiated after ponatinib approval in Germany. \[The decision to prescribe ponatinib must have been made prior to enrolment in the study. Patients enrolled in the retrospective part of the study may or may not be still on ponatinib treatment at the time informed consent is given. These retrospective patients should have started Treatment after 02.02.2015.\]. * Patients who have the ability to understand the requirements of the study, and provide written informed consent to comply with the study data collection procedures. * Patients with a minimum life expectancy of 3 months Exclusion Criteria: * Patients previously treated with investigational ponatinib (within a clinical trial) * Patients receiving an investigational agent * Patients who are pregnant and/or breastfeeding * Patients who are pregnant and/or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.