Clinical trial · Observational
Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium
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
NCT03678454CI-TRIAL-00057748completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| CML | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Ph+ ALL | — | UNRESOLVED | — |
| Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prescribed dose of Iclusig® in routine practice in Belgium
- timeFrame
- Up to 3 years
- description
- Prescribed dose of Iclusig® in milligrams.
Secondary outcomes (2)
- measure
- Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium
- timeFrame
- Up to 3 years
- description
- Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response.
- measure
- Estimate of additional health care utilization cost
- timeFrame
- Up to 3 years
- description
- Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDDevos 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 40811042