Clinical trial · Observational
A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
A Postmarketing Observational Cohort Study to Evaluate Effectiveness and Safety of Ponatinib (Iclusig®) in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Revisiting the availability of patients with Ph+ ALL that would meet the in-/exclusion criteria of the study led to the decision not to move forward.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®) in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical practice in Europe.
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 |
|---|---|---|---|
| BCR-ABL Positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Ph+ ALL Patients
- description
- Patients with Ph+ ALL being treated with Iclusig®.
Primary outcomes (1)
- measure
- Complete hematological remission (CR) rate
- timeFrame
- 6 months
- description
- CR defined as leukemic cells not detectable by light microscopy in bone marrow (BM), peripheral blood (PB), or cerebrospinal fluid (CSF) (BM \< 5% blasts).
Secondary outcomes (15)
- measure
- CR rate
- timeFrame
- 1, 3, 9, and 12 months
- description
- CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM \< 5% blasts).
- measure
- CR rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with BCR-ABL (Ph+) positive ALL who are initiating Iclusig®, or for whom Iclusig® was initiated after January 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. Exclusion Criteria: * Patients previously treated with investigational ponatinib. * Patients who are pregnant and/or breastfeeding. * Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.
References
Publications (0)
Data not yet available