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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ph+ ALL Patients | Patients with Ph+ ALL being treated with Iclusig®. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| CR rate | CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts). |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with Ph+ ALL being treated with Iclusig® in Europe.
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Hoelzer, Prof. Dr. med. | Oncologikum Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ihbt/Ăšhkt | Prague | 128 00 | Czechia | |||
| University Hospital Amiens |
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| 1, 3, 6, 9, and 12 months |
| Time to CR | Defined as time from enrollment to first CR. | Up to 12 months |
| Minimal residual disease (MRD) level | Minimal residual disease level. | 3, 6, 9, and 12 months |
| Best MRD (MolR) level rate | MolR defined as molecular/MRD response, less than MolCR. | 12 months |
| Time to best MRD (MolR) level | MolR defined as molecular/MRD response, less than MolCR. | Up to 12 months |
| Duration of molecular response | Measured by MRD log reduction (MolR). | Up to 12 months |
| Duration of best molecular response (MolCR) | MolCR defined as complete molecular remission/MRD negativity. | Up to 12 months |
| Time to progression | Defined as the time to molecular relapse or hematological relapse. | Up to 12 months |
| Time to death | Defined as time from enrollment to death due to any cause. | Up to 12 months |
| Prescribed dose | Prescribed dose of Iclusig® in milligrams. | Up to 12 months |
| Daily average dose | The average daily dose of Iclusig® in milligrams. | Up to 12 months |
| 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 |
| 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 |
| Amount of hospital days | Defined as overnight stay(s), each night in the hospital will be counted as 1 day. | 12 months |
| Amiens |
| 80080 |
| France |
| University Hospital Angers | Angers | 49100 | France |
| University Hospital Bordeaux | Bordeaux | 33000 | France |
| University Hospital Grenoble | Grenoble | 38700 | France |
| University Hospital Lyon | Lyon | 69361 | France |
| University Cancer Institute Oncopole | Toulouse | 31059 | France |
| University Hospital Halle/Saale | Halle | 06120 | Germany |
| University Hospital Munich | Munich | 81377 | Germany |
| University Hospital Rostock | Rostock | 18057 | Germany |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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