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This prospective registry is initiated to follow up on the use of Iclusig® in patients with CML or Ph+ ALL in routine practice in Belgium.
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| Measure | Description | Time Frame |
|---|---|---|
| Prescribed dose of Iclusig® in routine practice in Belgium | Prescribed dose of Iclusig® in milligrams. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium | Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response. | Up to 3 years |
| Estimate of additional health care utilization cost |
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Inclusion Criteria:
Patient with confirmed diagnosis of:
Patients on treatment with Iclusig® or prescribed for treatment with Iclusig® during the registry (treatment decisions should be taken outside the registry).
Written informed consent obtained from the patient, if still alive (NPP participants that were still on Iclusig® treatment on 01 March 2016, but who died before the start of this registry will be included without informed consent provided that a waiver is granted by the ethics committee for inclusion of these patients).
Exclusion Criteria:
• Concurrently participating in a clinical study, at any time during the registry period, in which the patient is exposed to Iclusig® or to another investigational product/ vaccine (pharmaceutical product/ device).
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The target population will include adult patients with CML or Ph+ ALL for whom the decision to initiate treatment with Iclusig® as per the indication in the product label has been made before entering in the registry. Approximately 25 haematology practices will be selected for participation in this registry.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Beck, PhD | Incyte Biosciences Benelux | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Stuyvenberg | Antwerp | 2060 | Belgium | |||
| UZ Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40811042 | Derived | Devos T, Deeren D, Theunissen K, Selleslag D, Bailly B, Havelange V, Lewalle P, Meers S, Benghiat FS, Gadisseur A, Granacher N, Vanstraelen G, Vellemans H, Becker A, Janssen M, Vrelust I, Lejeune M, Van de Velde A, Triffet A, Beck M, Sebti H, Mazure D. Real-world outcomes in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myeloid leukemia treated with ponatinib - final 6-year results from a Belgian registry. Hematology. 2025 Dec;30(1):2534196. doi: 10.1080/16078454.2025.2534196. Epub 2025 Aug 14. |
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Costs associated with the treatment of Iclusig®-related adverse events reported during the registry. |
| Up to 3 years |
| Antwerp |
| 2650 |
| Belgium |
| AZ Klina | Brasschaat | 2930 | Belgium |
| AZ St-Jan Brugge | Bruges | 8000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| CHU Brugmann | Brussels | 1020 | Belgium |
| Hopital Erasme | Brussels | 1070 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Clinique universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Ziekenhuis Oost Limburg (ZOL) | Ghent | 3600 | Belgium |
| Hopital Jolimont | Haine-Saint-Paul | 7100 | Belgium |
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU Sart Tilman Liège | Liège | 4000 | Belgium |
| CHU Charleroi Vésale | Montigny-le-Tilleul | 6110 | Belgium |
| AZ Turnhout St-Elisabeth | Turnhout | 2300 | Belgium |
| CHR La Tourelle | Verviers | 4800 | Belgium |
| CHU/UCL Namur Mont-Godinne | Yvoir | 5530 | Belgium |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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