Clinical trial NCT03678454: Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Prescribed dose of Iclusig® in routine practice in Belgium
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium
timeFrame: Up to 3 years
measure: Estimate of additional health care utilization cost
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Stuyvenberg
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ St-Jan Brugge
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Brussels
country: Belgium
facility: UZ Brussel
city: Brussels
country: Belgium
facility: Clinique universitaires Saint-Luc
city: Gent
country: Belgium
facility: Ziekenhuis Oost Limburg (ZOL)
city: Haine-Saint-Paul
country: Belgium
facility: Hopital Jolimont
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU Sart Tilman Liège
city: Montigny-le-Tilleul
country: Belgium
facility: CHU Charleroi Vésale
city: Turnhout
country: Belgium
facility: AZ Turnhout St-Elisabeth
city: Verviers
country: Belgium
facility: CHR La Tourelle
city: Yvoir
country: Belgium
facility: CHU/UCL Namur Mont-Godinne
Study officials:
affiliation: Incyte Biosciences Benelux
name: Michael Beck, PhD
role: STUDY_DIRECTOR
References: