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

Chronic Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678454
• Other study ID #: Incyte-30006
• Status: Completed
• Start date: February 3, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• CML
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Ph+ ALL
• Philadelphia Chromosome
• Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Antwerpen
Belgium	ZNA Stuyvenberg	Antwerpen
Belgium	AZ Klina	Brasschaat
Belgium	AZ St-Jan Brugge	Brugge
Belgium	CHU Brugmann	Brussels
Belgium	Clinique universitaires Saint-Luc	Brussels
Belgium	Hopital Erasme	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	UZ Brussel	Brussels
Belgium	Ziekenhuis Oost Limburg (ZOL)	Gent
Belgium	Hopital Jolimont	Haine-Saint-Paul
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven	Leuven
Belgium	CHU Sart Tilman Liège	Liège
Belgium	CHU Charleroi Vésale	Montigny-le-Tilleul
Belgium	AZ Turnhout St-Elisabeth	Turnhout
Belgium	CHR La Tourelle	Verviers
Belgium	CHU/UCL Namur Mont-Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Biosciences Benelux

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescribed dose of Iclusig® in routine practice in Belgium	Prescribed dose of Iclusig® in milligrams.	Up to 3 years
Secondary	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.	Up to 3 years
Secondary	Estimate of additional health care utilization cost	Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.	Up to 3 years