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

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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases CML Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Ph+ ALL Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Antwerpen, Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

Prescribed dose of Iclusig® in routine practice in Belgium

Time frame: Up to 3 years

Prescribed dose of Iclusig® in milligrams.

Secondary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Incyte Biosciences Benelux

Industry

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Sep 19, 2018
Registry last updated: Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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