Prospective Registry of Ponatinib in Belgium [Belgium]
Study title
Scientific title
Prospective registry of Iclusig® (ponatinib) used in clinical practice for the treatment of patients with Chronic Myeloid Leukemia or CML or Ph+ Acute Lymphoblastic Leukemia in Belgium (ClinicalTrials.gov NCT03678454)
Type of study
Other trials
Current status
No longer recruiting
What is the purpose of the study
This prospective registry aims to gather specific data on Iclusig® usage in routine practice on treatment dosage and duration up to 3 years after reimbursement in Belgium.
Secondary objectives are:
– To describe demographic and disease characteristics for patients with CML or Ph+aLL receiving Iclusig®.
– To describe Iclusig® treatment outcomes.
– To estimate the additional health care utilisation cost associated with the treatment of Iclusig® related adverse events reported during the registry
Key inclusion criteria
This registry will be open to all patients who:
– Received Iclusig® through the named patient program (NPP) prior to 01 March 2016 AND were still on Iclusig® treatment on 01 March 2016.
– Were put on Iclusig® treatment between 01 March 2016 and registry start.
– Will be put on Iclusig® treatment up to 3 years after reimbursement of Iclusig® in Belgium (01 March 2019).
1. Patients aged 18 years or older with a confirmed diagnosis of Chronic Myeloid Leukemia (CML) (chronic, accelerated or blast phase) who are resistant or intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation;
OR
Patients with a confirmed diagnosis of Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) who are resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation.
3. Patients on treatment with Iclusig® or who have been prescribed treatment with Iclusig® during the registry (treatment decisions should be taken outside the registry).
The patient must not be included in the registry if he/she is 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).
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Incyte Biosciences Benelux
Scientific lead / contact
Study Director: Marcel Koopman, Incyte Biosciences Benelux
Principal investigator
There is no principal investigator as this is a registry.
Study centers / principal investigators
Belgium
ZNA Stuyvenberg
Antwerpen, 2060
UZ Antwerpen
Antwerpen, 2650
AZ Klina
Brasschaat, 2930
AZ St-Jan Brugge
Brugge, 8000
Institut Jules Bordet
Brussels, 1000
CHU Brugmann
Brussels, 1020
Hopital Erasme
Brussels, 1070
UZ Brussel
Brussels, 1090
Clinique universitaires Saint-Luc
Brussels, 1200
Ziekenhuis Oost Limburg (ZOL)
Gent, 3600
Hopital Jolimont
Haine-Saint-Paul, 7100
Jessa Ziekenhuis
Hasselt, 3500
AZ Groeninge
Kortrijk, 8500
UZ Leuven
Leuven, 3000
CHU Sart Tilman Liège
Liège, 4000
CHU Charleroi Vésale
Montigny-le-Tilleul, 6110
AZ Turnhout St-Elisabeth
Turnhout, 2300
CHR La Tourelle
Verviers, 4800
CHU/UCL Namur Mont-Godinne
Yvoir, 5530