Prospective Registry of Ponatinib in Belgium [Belgium]
Type of study
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
What will happen during the study
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;
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
Incyte Biosciences Benelux
Scientific lead / contact
Study Director: Marcel Koopman, Incyte Biosciences Benelux
There is no principal investigator as this is a registry.
Study centers / principal investigators
AZ St-Jan Brugge
Institut Jules Bordet
Clinique universitaires Saint-Luc
Ziekenhuis Oost Limburg (ZOL)
CHU Sart Tilman Liège
CHU Charleroi Vésale
AZ Turnhout St-Elisabeth
CHR La Tourelle
CHU/UCL Namur Mont-Godinne