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CompletedNCT03678454Updated Apr 12, 2022

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

An observational study in Chronic Myeloid Leukemia, CML and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia, sponsored by Incyte Biosciences Benelux. Completed at 19 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by Incyte Biosciences Benelux · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Myeloid Leukemia
  • CML
  • Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
  • Ph+ ALL

Keywords

  • Chronic myeloid leukemia
  • Philadelphia chromosome positive acute lymphoblastic leukemia
  • Iclusig®
  • ponatinib
03

In context

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

982 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.

This study's enrollment of 80 is below the median of 129 across 152 observational studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →

Lead sponsor

This is the only study on the registry with Incyte Biosciences Benelux as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prescribed dose of Iclusig® in routine practice in Belgium

    Prescribed dose of Iclusig® in milligrams.

    Time frame: Up to 3 years

Secondary outcomes

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

    Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response.

    Time frame: Up to 3 years

  2. Estimate of additional health care utilization cost

    Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.

    Time frame: Up to 3 years

07

Study locations

19 sites
  • ZNA Stuyvenberg
    Antwerp, 2060, Belgium
  • UZ Antwerpen
    Antwerp, 2650, Belgium
  • AZ Klina
    Brasschaat, 2930, Belgium
  • AZ St-Jan Brugge
    Bruges, 8000, Belgium
  • Institut Jules Bordet
    Brussels, 1000, Belgium
  • CHU Brugmann
    Brussels, 1020, Belgium
  • Hopital Erasme
    Brussels, 1070, Belgium
  • UZ Brussel
    Brussels, 1090, Belgium
  • Clinique universitaires Saint-Luc
    Brussels, 1200, Belgium
  • Ziekenhuis Oost Limburg (ZOL)
    Ghent, 3600, Belgium
  • Hopital Jolimont
    Haine-Saint-Paul, 7100, Belgium
  • Jessa Ziekenhuis
    Hasselt, 3500, Belgium
  • AZ Groeninge
    Kortrijk, 8500, Belgium
  • UZ Leuven
    Leuven, 3000, Belgium
  • CHU Sart Tilman Liège
    Liège, 4000, Belgium
  • CHU Charleroi Vésale
    Montigny-le-Tilleul, 6110, Belgium
  • AZ Turnhout St-Elisabeth
    Turnhout, 2300, Belgium
  • CHR La Tourelle
    Verviers, 4800, Belgium
  • CHU/UCL Namur Mont-Godinne
    Yvoir, 5530, Belgium
08

References and documents

Publications

  • Devos T, Deeren D, Theunissen K, Selleslag D, Bailly B, Havelange V, Lewalle P, Meers S, Benghiat FS, Gadisseur A, Granacher N, Vanstraelen G, Vellemans H, Becker A, Janssen M, Vrelust I, Lejeune M, Van de Velde A, Triffet A, Beck M, Sebti H, Mazure D. Real-world outcomes in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myeloid leukemia treated with ponatinib - final 6-year results from a Belgian registry. Hematology. 2025 Dec;30(1):2534196. doi: 10.1080/16078454.2025.2534196. Epub 2025 Aug 14. PubMed 40811042 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03678454
Lead sponsor
Incyte Biosciences Benelux
Responsible party
Sponsor
First posted
Sep 19, 2018
Start date
Feb 3, 2017
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022
Last update
Apr 12, 2022

Study contacts

Michael Beck, PhD
study director · Incyte Biosciences Benelux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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