NCT03678454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

5.2 years

First QC Date

September 18, 2018

Last Update Submit

April 11, 2022

Conditions

Chronic Myeloid LeukemiaCMLPhiladelphia Chromosome-positive Acute Lymphoblastic LeukemiaPh+ ALL

Keywords

Chronic myeloid leukemiaPhiladelphia chromosome positive acute lymphoblastic leukemiaIclusig®ponatinib

Outcome Measures

Primary Outcomes (1)

  • Prescribed dose of Iclusig® in routine practice in Belgium

    Prescribed dose of Iclusig® in milligrams.

    Up to 3 years

Secondary Outcomes (2)

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

    Up to 3 years

  • Estimate of additional health care utilization cost

    Up to 3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

ZNA Stuyvenberg

Antwerp, 2060, Belgium

Location

UZ Antwerpen

Antwerp, 2650, Belgium

Location

AZ Klina

Brasschaat, 2930, Belgium

Location

AZ St-Jan Brugge

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

Hopital Erasme

Brussels, 1070, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Clinique universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Ziekenhuis Oost Limburg (ZOL)

Ghent, 3600, Belgium

Location

Hopital Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU Sart Tilman Liège

Liège, 4000, Belgium

Location

CHU Charleroi Vésale

Montigny-le-Tilleul, 6110, Belgium

Location

AZ Turnhout St-Elisabeth

Turnhout, 2300, Belgium

Location

CHR La Tourelle

Verviers, 4800, Belgium

Location

CHU/UCL Namur Mont-Godinne

Yvoir, 5530, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 40811042DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Beck, PhD

    Incyte Biosciences Benelux

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 19, 2018

Study Start

February 3, 2017

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

BE(19)