Iclusig® (Ponatinib) in Clinical Practice for the Treatment of 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.
|Condition or Disease||Intervention/Treatment||Phase|
Primary Outcome Measures
- Prescribed dose of Iclusig® in routine practice in Belgium [Up to 3 years]
Prescribed dose of Iclusig® in milligrams.
Secondary Outcome Measures
- Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium [Up to 3 years]
Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response.
- Estimate of additional health care utilization cost [Up to 3 years]
Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.
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).
• 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).
Contacts and Locations
|4||AZ St-Jan Brugge||Brugge||Belgium||8000|
|5||Institut Jules Bordet||Brussels||Belgium||1000|
|9||Clinique universitaires Saint-Luc||Brussels||Belgium||1200|
|10||Ziekenhuis Oost Limburg (ZOL)||Gent||Belgium||3600|
|15||CHU Sart Tilman Liège||Liège||Belgium||4000|
|16||CHU Charleroi Vésale||Montigny-le-Tilleul||Belgium||6110|
|17||AZ Turnhout St-Elisabeth||Turnhout||Belgium||2300|
|18||CHR La Tourelle||Verviers||Belgium||4800|
|19||CHU/UCL Namur Mont-Godinne||Yvoir||Belgium||5530|
Sponsors and Collaborators
- Incyte Biosciences Benelux
- Study Director: Marcel Koopman, Incyte Biosciences Benelux
Study Documents (Full-Text)None provided.