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

April 11, 2022 updated by: Incyte Biosciences Benelux

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2650
        • UZ Antwerpen
      • Antwerpen, Belgium, 2060
        • ZNA Stuyvenberg
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brugge, Belgium, 8000
        • AZ St-Jan Brugge
      • Brussels, Belgium, 1020
        • CHU Brugmann
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1070
        • Hopital Erasme
      • Brussels, Belgium, 1200
        • Clinique Universitaires Saint-Luc
      • Gent, Belgium, 3600
        • Ziekenhuis Oost Limburg (ZOL)
      • Haine-Saint-Paul, Belgium, 7100
        • Hopital Jolimont
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU Sart Tilman Liege
      • Montigny-le-Tilleul, Belgium, 6110
        • CHU Charleroi Vésale
      • Turnhout, Belgium, 2300
        • AZ Turnhout St-Elisabeth
      • Verviers, Belgium, 4800
        • CHR La Tourelle
      • Yvoir, Belgium, 5530
        • CHU/UCL Namur Mont-Godinne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population will include adult patients with CML or Ph+ ALL for whom the decision to initiate treatment with Iclusig® as per the indication in the product label has been made before entering in the registry. Approximately 25 haematology practices will be selected for participation in this registry.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prescribed dose of Iclusig® in routine practice in Belgium
Time Frame: Up to 3 years
Prescribed dose of Iclusig® in milligrams.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium
Time Frame: Up to 3 years
Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response.
Up to 3 years
Estimate of additional health care utilization cost
Time Frame: Up to 3 years
Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Biosciences Benelux

Investigators

  • Study Director: Michael Beck, PhD, Incyte Biosciences Benelux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2017

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Incyte-30006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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