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

Sponsor
Incyte Biosciences Benelux (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03678454
Collaborator
(none)
125
Enrollment
19
Locations
65.8
Anticipated Duration (Months)
6.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
125 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Actual Study Start Date :
Feb 3, 2017
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Prescribed dose of Iclusig® in routine practice in Belgium [Up to 3 years]

    Prescribed dose of Iclusig® in milligrams.

Secondary Outcome Measures

  1. Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium [Up to 3 years]

    Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response.

  2. Estimate of additional health care utilization cost [Up to 3 years]

    Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1ZNA StuyvenbergAntwerpenBelgium2060
2UZ AntwerpenAntwerpenBelgium2650
3AZ KlinaBrasschaatBelgium2930
4AZ St-Jan BruggeBruggeBelgium8000
5Institut Jules BordetBrusselsBelgium1000
6CHU BrugmannBrusselsBelgium1020
7Hopital ErasmeBrusselsBelgium1070
8UZ BrusselBrusselsBelgium1090
9Clinique universitaires Saint-LucBrusselsBelgium1200
10Ziekenhuis Oost Limburg (ZOL)GentBelgium3600
11Hopital JolimontHaine-Saint-PaulBelgium7100
12Jessa ZiekenhuisHasseltBelgium3500
13AZ GroeningeKortrijkBelgium8500
14UZ LeuvenLeuvenBelgium3000
15CHU Sart Tilman LiègeLiègeBelgium4000
16CHU Charleroi VésaleMontigny-le-TilleulBelgium6110
17AZ Turnhout St-ElisabethTurnhoutBelgium2300
18CHR La TourelleVerviersBelgium4800
19CHU/UCL Namur Mont-GodinneYvoirBelgium5530

Sponsors and Collaborators

  • Incyte Biosciences Benelux

Investigators

  • Study Director: Marcel Koopman, Incyte Biosciences Benelux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Incyte Biosciences Benelux
ClinicalTrials.gov Identifier:
NCT03678454
Other Study ID Numbers:
  • Incyte-30006
First Posted:
Sep 19, 2018
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022

Study Results

No Results Posted as of Apr 1, 2022