Chronic Myeloid Leukemia, CML, Ph+ ALL, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Conditions
Keywords
Chronic myeloid leukemia, Philadelphia chromosome positive acute lymphoblastic leukemia, Iclusig®, ponatinib
Brief summary
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.
Interventions
None listed
Sponsors
Incyte Biosciences Benelux
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prescribed dose of Iclusig® in routine practice in Belgium | Up to 3 years | Prescribed dose of Iclusig® in milligrams. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium
Outcome results
None listed