Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

Prospective Registry of Iclusig® (Ponatinib) Used in Clinical Practice for the Treatment of Patients With Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

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.

Inclusion Criteria:

• Patient with confirmed diagnosis of:

  • CML (chronic, accelerated or blast phase) who is resistant or intolerant to dasatinib or nilotinib; and for whom subsequent treatment with imatinib is not clinically appropriate; or who has the T315I mutation.
  • Ph+ ALL who is resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who has the T315I mutation.

• 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).