coiaward2010

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

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 at time of starting treatment with Iclusig®.

2. Patients 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

Scientific lead / contact

Prof. Timothy Devos, UZ Leuven, Belgium

Principal investigator

There is no principal investigator as this is a registry.

Additional information

Study centers / principal investigators

Belgium

UZ Leuven
Prof. Timothy Devos
Herestraat 49
3000 Leuven

The registry is open to all hemato-centers in Belgium with patients on ponatinib.

 


 
   
 

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