BCR-ABL Positive Acute Lymphoblastic Leukemia Clinical Trial
Official title:
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"
| Verified date | December 2018 |
| Source | Incyte Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 2021 |
| Est. primary completion date | March 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Ihbt/Úhkt | Praha | |
| France | University Hospital Amiens | Amiens | |
| France | University Hospital Angers | Angers | |
| France | University Hospital Bordeaux | Bordeaux | |
| France | University Hospital Grenoble | Grenoble | |
| France | University Hospital Lyon | Lyon | |
| France | University Cancer Institute Oncopole | Toulouse | |
| Germany | University Hospital Halle/Saale | Halle/Saale | |
| Germany | University Hospital Munich | Munich | |
| Germany | University Hospital Rostock | Rostock |
| Lead Sponsor | Collaborator |
|---|---|
| Incyte Biosciences International Sàrl |
Czechia, France, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete hematological remission (CR) rate | CR defined as leukemic cells not detectable by light microscopy in bone marrow (BM), peripheral blood (PB), or cerebrospinal fluid (CSF) (BM < 5% blasts). | 6 months | |
| Secondary | CR rate | CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts). | 1, 3, 9, and 12 months | |
| Secondary | CR rate | CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts). | 1, 3, 6, 9, and 12 months | |
| Secondary | Time to CR | Defined as time from enrollment to first CR. | Up to 12 months | |
| Secondary | Minimal residual disease (MRD) level | Minimal residual disease level. | 3, 6, 9, and 12 months | |
| Secondary | Best MRD (MolR) level rate | MolR defined as molecular/MRD response, less than MolCR. | 12 months | |
| Secondary | Time to best MRD (MolR) level | MolR defined as molecular/MRD response, less than MolCR. | Up to 12 months | |
| Secondary | Duration of molecular response | Measured by MRD log reduction (MolR). | Up to 12 months | |
| Secondary | Duration of best molecular response (MolCR) | MolCR defined as complete molecular remission/MRD negativity. | Up to 12 months | |
| Secondary | Time to progression | Defined as the time to molecular relapse or hematological relapse. | Up to 12 months | |
| Secondary | Time to death | Defined as time from enrollment to death due to any cause. | Up to 12 months | |
| Secondary | Prescribed dose | Prescribed dose of Iclusig® in milligrams. | Up to 12 months | |
| Secondary | Daily average dose | The average daily dose of Iclusig® in milligrams. | Up to 12 months | |
| Secondary | Number of serious adverse events (SAEs) | 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. | 12 months | |
| Secondary | Number of adverse events of special interest (AESI) | AESI defined as vascular occlusive events, including arterial and venous events, as defined in the protocol. | 12 months | |
| Secondary | Amount of hospital days | Defined as overnight stay(s), each night in the hospital will be counted as 1 day. | 12 months |