Prospective Registry of Ponatinib in Belgium [Belgium]

Study title

Prospective registry of ponatinib in clinical practice for CML or Ph+ ALL in Belgium

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)

Indication and most important 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).

Inclusion criteria:

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).

Short description of intervention

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

Type of study

Other trials

Current status

Recruiting

Study sponsor

Incyte Biosciences Benelux

ScientificIncyte Biosciences Benelux lead / contact

Study Director: Marcel Koopman, Incyte Biosciences Benelux

Principal investigator

There is no principal investigator as this is a registry.

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

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


 
   
 

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