A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
- Conditions
- BCR-ABL Positive Acute Lymphoblastic Leukemia
- Registration Number
- NCT03515785
- Lead Sponsor
- Incyte Biosciences International Sàrl
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- Patients previously treated with investigational ponatinib.
- Patients who are pregnant and/or breastfeeding.
- Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
Daily average dose Up to 12 months The average daily dose of Iclusig® in milligrams.
Amount of hospital days 12 months Defined as overnight stay(s), each night in the hospital will be counted as 1 day.
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.
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.
Prescribed dose Up to 12 months Prescribed 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.
Trial Locations
- Locations (10)
University Hospital Bordeaux
🇫🇷Bordeaux, France
University Hospital Lyon
🇫🇷Lyon, France
University Hospital Amiens
🇫🇷Amiens, France
University Hospital Angers
🇫🇷Angers, France
Ihbt/Úhkt
🇨🇿Praha, Czechia
University Hospital Halle/Saale
🇩🇪Halle/Saale, Germany
University Hospital Munich
🇩🇪Munich, Germany
University Cancer Institute Oncopole
🇫🇷Toulouse, France
University Hospital Grenoble
🇫🇷Grenoble, France
University Hospital Rostock
🇩🇪Rostock, Germany