Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®)

NCT ID: NCT04048564

Last Updated: 2023-09-28

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

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-23

Study Completion Date

2023-07-03

Brief Summary

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This is a multicentre ambispective cohort study involving French patients who have started or are receiving for less than 6 months a treatment with ponatinib. This study aims at better qualifying the ponatinib benefit-risk balance in real life and in relation with CML patients' therapeutic history.

Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Presenting a CML in any phase.
* Having initiated for less than six months a treatment with ponatinib.
* The ability to understand the requirements of the study and to comply with the study data collection procedures.

Exclusion Criteria

* Patients previously treated with investigational ponatinib (within a clinical trial).
* Patients receiving an investigational agent.
* Patients who are pregnant and/or breastfeeding.
* Patients with contraindications for Ponatinib according to Summary of Products Characteristics.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte BioSciences France

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali G. Turnan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Paris Sud University Hospitals-Bicetre

Locations

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CHU SUD Reunion GHSR

Saint-Pierre, Reunion, France

Site Status

CHU Amiens-Picardie- Site SUD

Amiens, , France

Site Status

CHU D'Angers

Angers, , France

Site Status

CH Annecy

Annecy, , France

Site Status

Centre Hospitalier Argenteuil

Argenteuil, , France

Site Status

Centre Hospitalier D'Avignon

Avignon, , France

Site Status

CH Beziers

Béziers, , France

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Cabinet D'hematologie De La Clinique Du Parc

Castelnau-le-Lez, , France

Site Status

CH William Morey

Chalon-sur-Saône, , France

Site Status

CH Chambery

Chambéry, , France

Site Status

CHU Estaing Clermont Ferrand

Clermont-Ferrand, , France

Site Status

CHU Dijon, François Mitterrand

Dijon, , France

Site Status

Centre Hospitalier De Dunkerque

Dunkirk, , France

Site Status

Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, , France

Site Status

CH De Versailles (Andre Mignot)

Le Chesnay, , France

Site Status

Hopital Bicetre

Le Kremlin-Bicêtre, , France

Site Status

CH De Libourne

Libourne, , France

Site Status

CHRU De Lille - Hôpital Huriez

Lille, , France

Site Status

CH Limoges

Limoges, , France

Site Status

Leon Berard, Lyon

Lyon, , France

Site Status

Centre Hospitalier De Meaux

Meaux, , France

Site Status

Hopitaux Prives Metz Centre De Belle-Isle

Metz, , France

Site Status

CH De Metz (Hopital De Mercy - CHR Metz Thionville)

Metz, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

Hopital Salpetriere

Paris, , France

Site Status

La Pitié Salpêtrière - Paris

Paris, , France

Site Status

Hopital Necker

Paris, , France

Site Status

CH St Jean

Perpignan, , France

Site Status

CHU De Poitiers

Poitiers, , France

Site Status

Hôpital Rene Dubos

Pontoise, , France

Site Status

CH De Cornouaille

Quimper, , France

Site Status

CHU De Rennes

Rennes, , France

Site Status

Hopital Victor Provo

Roubaix, , France

Site Status

La Clinique Sainte-Anne

Strasbourg, , France

Site Status

CHRU Strasbourg

Strasbourg, , France

Site Status

Institut Universitaire Du Cancer Toulouse - Oncopo

Toulouse, , France

Site Status

CH Troyes

Troyes, , France

Site Status

CHRU De Nancy - Hôpitaux De Brabois

Vandœuvre-lès-Nancy, , France

Site Status

CHU Sud, St Pierre - La Réunion

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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Huguet F, Guerci-Bresler A, Roth-Guepin G, Cayssials E, Slama B, Santagostino A, Penot A, Quittet P, Cony-Makhoul P, Saad A, Bastie JN, Hacini M, Coiteux V, Uzunov M, Roy L, Le Clech L, Berger M, Agneray AM, Messas E, Etienne G, Turhan A, Nicolini FE, Rousselot P. Clinical outcomes in patients in any phase of CML treated with ponatinib in France-Data from the TOPASE observational study. Br J Haematol. 2024 Dec;205(6):2295-2304. doi: 10.1111/bjh.19819. Epub 2024 Nov 6.

Reference Type DERIVED
PMID: 39506529 (View on PubMed)

Other Identifiers

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2017-A01355-48

Identifier Type: -

Identifier Source: org_study_id

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