Chronic Myeloid LeukemiaNCT03678454
Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium
An observational study of Chronic Myeloid Leukemia and CML, run by Incyte Biosciences Benelux at 19 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, CML, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
- How many people
- 80 participants
- Where
- 19 sitesBelgium
- Study dates
- 3 Feb 2017to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Belgium19 sites
ZNA Stuyvenberg
Antwerp, 2060
UZ Antwerpen
Antwerp, 2650
AZ Klina
Brasschaat, 2930
AZ St-Jan Brugge
Bruges, 8000
Institut Jules Bordet
Brussels, 1000
CHU Brugmann
Brussels, 1020
Hopital Erasme
Brussels, 1070
UZ Brussel
Brussels, 1090
Clinique universitaires Saint-Luc
Brussels, 1200
Ziekenhuis Oost Limburg (ZOL)
Ghent, 3600
Hopital Jolimont
Haine-Saint-Paul, 7100
Jessa Ziekenhuis
Hasselt, 3500
AZ Groeninge
Kortrijk, 8500
UZ Leuven
Leuven, 3000
CHU Sart Tilman Liège
Liège, 4000
CHU Charleroi Vésale
Montigny-le-Tilleul, 6110
AZ Turnhout St-Elisabeth
Turnhout, 2300
CHR La Tourelle
Verviers, 4800
CHU/UCL Namur Mont-Godinne
Yvoir, 5530
About this study
Official title: 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.
- Conditions
- Chronic Myeloid Leukemia, CML, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia, Ph+ ALL
- Keywords
- Chronic myeloid leukemia, Philadelphia chromosome positive acute lymphoblastic leukemia, Iclusig®, ponatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescribed dose of Iclusig® in routine practice in Belgium
Prescribed dose of Iclusig® in milligrams.
Measured: Up to 3 years
Secondary outcomes (2)
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.
Measured: Up to 3 years
Estimate of additional health care utilization cost
Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start3 Feb 2017
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences Benelux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Beck, PhD, Study director, Incyte Biosciences Benelux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678454
- Sponsor's protocol ID
- Incyte-30006
- Status last verified
- Apr 2022
- First submitted
- 18 Sep 2018
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03678454
- Acronym / sponsor ID
- Incyte-30006
- Conditions
- Chronic Myeloid Leukemia, CML, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia, Ph+ ALL
- Keywords
- Chronic myeloid leukemia, Philadelphia chromosome positive acute lymphoblastic leukemia, Iclusig®, ponatinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Incyte Biosciences BeneluxIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patient with confirmed diagnosis of:
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prescribed dose of Iclusig® in routine practice in Belgium
Time frame: Up to 3 years
Prescribed dose of Iclusig® in milligrams.
2 secondary outcomes
Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium
Time frame: Up to 3 years
Estimate of additional health care utilization cost
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 40811042Devos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Beck, PhD study director
Incyte Biosciences Benelux
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia and CML, run by Incyte Biosciences Benelux at 19 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescribed dose of Iclusig® in routine practice in Belgium (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03678454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.