Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03678454
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences Benelux )

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.

Condition or disease
Chronic Myeloid Leukemia CML Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia Ph+ ALL

Layout table for study information
Study Type : Observational
Estimated 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 : February 3, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : July 31, 2022





Primary Outcome Measures :
  1. Prescribed dose of Iclusig® in routine practice in Belgium [ Time Frame: 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 [ Time Frame: Up to 3 years ]
    Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response.

  2. Estimate of additional health care utilization cost [ Time Frame: Up to 3 years ]
    Costs associated with the treatment of Iclusig®-related adverse events reported during the registry.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678454


Contacts
Layout table for location contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Incyte Biosciences Benelux
Investigators
Layout table for investigator information
Study Director: Marcel Koopman Incyte Biosciences Benelux
Layout table for additonal information
Responsible Party: Incyte Biosciences Benelux
ClinicalTrials.gov Identifier: NCT03678454    
Other Study ID Numbers: Incyte-30006
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation ( Incyte Biosciences Benelux ):
Chronic myeloid leukemia
Philadelphia chromosome positive acute lymphoblastic leukemia
Iclusig®
ponatinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes