A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ph+ ALL Patients Patients with Ph+ ALL being treated with Iclusig®. |
Outcome Measures
Primary Outcome Measures
- Complete hematological remission (CR) rate [6 months]
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 Outcome Measures
- CR rate [1, 3, 9, and 12 months]
CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts).
- CR rate [1, 3, 6, 9, and 12 months]
CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts).
- Time to CR [Up to 12 months]
Defined as time from enrollment to first CR.
- Minimal residual disease (MRD) level [3, 6, 9, and 12 months]
Minimal residual disease level.
- Best MRD (MolR) level rate [12 months]
MolR defined as molecular/MRD response, less than MolCR.
- Time to best MRD (MolR) level [Up to 12 months]
MolR defined as molecular/MRD response, less than MolCR.
- Duration of molecular response [Up to 12 months]
Measured by MRD log reduction (MolR).
- Duration of best molecular response (MolCR) [Up to 12 months]
MolCR defined as complete molecular remission/MRD negativity.
- Time to progression [Up to 12 months]
Defined as the time to molecular relapse or hematological relapse.
- Time to death [Up to 12 months]
Defined as time from enrollment to death due to any cause.
- Prescribed dose [Up to 12 months]
Prescribed dose of Iclusig® in milligrams.
- Daily average dose [Up to 12 months]
The average daily dose of Iclusig® in milligrams.
- Number of serious adverse events (SAEs) [12 months]
Defined as an adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is an important medical event.
- Number of adverse events of special interest (AESI) [12 months]
AESI defined as vascular occlusive events, including arterial and venous events, as defined in the protocol.
- Amount of hospital days [12 months]
Defined as overnight stay(s), each night in the hospital will be counted as 1 day.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients with BCR-ABL (Ph+) positive ALL who are initiating Iclusig®, or for whom Iclusig® was initiated after January 2015.
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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:
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Patients previously treated with investigational ponatinib.
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Patients who are pregnant and/or breastfeeding.
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Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ihbt/Úhkt | Praha | Czechia | 128 00 | |
| 2 | University Hospital Amiens | Amiens | France | 80080 | |
| 3 | University Hospital Angers | Angers | France | 49100 | |
| 4 | University Hospital Bordeaux | Bordeaux | France | 33000 | |
| 5 | University Hospital Grenoble | Grenoble | France | 38700 | |
| 6 | University Hospital Lyon | Lyon | France | 69361 | |
| 7 | University Cancer Institute Oncopole | Toulouse | France | 31059 | |
| 8 | University Hospital Halle/Saale | Halle/Saale | Germany | 06120 | |
| 9 | University Hospital Munich | Munich | Germany | 81377 | |
| 10 | University Hospital Rostock | Rostock | Germany | 18057 |
Sponsors and Collaborators
- Incyte Biosciences International Sàrl
Investigators
- Principal Investigator: Dieter Hoelzer, Prof. Dr. med., Oncologikum Frankfurt
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INCB-DEMA-ALL-401