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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03678454
Other study ID # Incyte-30006
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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