A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"

NCT ID: NCT03515785

Last Updated: 2018-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-31

Study Completion Date

2021-03-31

Brief Summary

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The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®) in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical practice in Europe.

Detailed Description

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Conditions

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BCR-ABL Positive Acute Lymphoblastic Leukemia

Keywords

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acute lymphoblastic leukemia ponatinib tyrosine kinase inhibitor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Ph+ ALL Patients

Patients with Ph+ ALL being treated with Iclusig®.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients with BCR-ABL (Ph+) positive ALL who are initiating Iclusig®, or for whom Iclusig® was initiated after January 2015.
* Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures.

Exclusion Criteria

* Patients previously treated with investigational ponatinib.
* Patients who are pregnant and/or breastfeeding.
* Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Biosciences International Sàrl

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dieter Hoelzer, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Oncologikum Frankfurt

Locations

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Ihbt/Úhkt

Prague, , Czechia

Site Status

University Hospital Amiens

Amiens, , France

Site Status

University Hospital Angers

Angers, , France

Site Status

University Hospital Bordeaux

Bordeaux, , France

Site Status

University Hospital Grenoble

Grenoble, , France

Site Status

University Hospital Lyon

Lyon, , France

Site Status

University Cancer Institute Oncopole

Toulouse, , France

Site Status

University Hospital Halle/Saale

Halle, , Germany

Site Status

University Hospital Munich

Munich, , Germany

Site Status

University Hospital Rostock

Rostock, , Germany

Site Status

Countries

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Austria Czechia France Germany

Other Identifiers

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INCB-DEMA-ALL-401

Identifier Type: -

Identifier Source: org_study_id