Leukemia - CML, Leukemia - ALL

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

Incyte Study ID:
Incyte-30006
CT.gov ID:
NCT03678454
View Results Summary
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Biosciences Benelux
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Leukemia - CML
  • Leukemia - ALL
    • PRODUCT
    N/A
    COLLABORATORS
    N/A
    DATE
    Feb 2017 - Mar 2022
    TYPE
    Observational
    PHASE
    N/A
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    UZ Leuven
    Leuven, Belgium, 3000
    Name
    Clinique universitaires Saint-Luc
    Brussels, Belgium, 1200
    Name
    ZNA Stuyvenberg
    Antwerpen, Belgium, 2060
    Name
    CHU/UCL Namur Mont-Godinne
    Yvoir, Belgium, 5530
    Name
    UZ Antwerpen
    Antwerpen, Belgium, 2650
    Name
    Hopital Jolimont
    Haine-Saint-Paul, Belgium, 7100
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    Key Inclusion and Exclusion Criteria

    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.

    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).
    Requirements information
    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).

    Protocol Summary

    Incyte Study ID:
    Incyte-30006
    Primary Purpose:
    N/A
    Allocation:
    N/A
    Study Design:
    N/A
    Masking:
    N/A
    Interventions:
    N/A
    Enrollment:
    80
    Primary Outcome
    Open

    Prescribed dose of Iclusig® in routine practice in Belgium

    Timeframe: Up to 3 years

    Secondary Outcome
    Open

    Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium

    Timeframe: Up to 3 years

    Estimate of additional health care utilization cost

    Timeframe: Up to 3 years