Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®)
1 other identifier
observational
120
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2018
CompletedFirst Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2023
CompletedSeptember 28, 2023
September 1, 2023
4.9 years
August 6, 2019
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
For participants in chronic myeloid leukemia in chronic (CP-CML) phase: Proportion of participants who achieve a major molecular response after the initiation of study treatment
Chronic myeloid leukemia (CML) response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia (Hochhaus et al Leukemia 2020).
from 24-60 months
For participants in chronic myeloid leukemia in accelerated phase (AP-CML) or chronic myeloid leukemia in blast phase (BP-CML): Proportion of participants who achieve a complete hematologic response
CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia.
from 24-60 months
Secondary Outcomes (14)
Proportion of participants in CP-CML phase who achieved complete hematologic response
from 24-60 months
Proportion of participants in AP and BP phases who achieved major (complete + partial) cytogenetic response
from 24-60 months
Proportion of participants who achieved major molecular response and/or depth molecular response: (MR4 or MR4.5 or MR5)
from 24-60 months
Duration of response
from 24-60 months
Time to progression to AP-CML or BP-CML (for those participants not in AP-CML or BP-CML)
from 24-60 months
- +9 more secondary outcomes
Eligibility Criteria
70 public and private French investigative centers of hematology will be recruited.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
CHU SUD Reunion GHSR
Saint-Pierre, Reunion, 97410, France
CHU Amiens-Picardie- Site SUD
Amiens, 80054, France
CHU D'Angers
Angers, 49100, France
CH Annecy
Annecy, 74370, France
Centre Hospitalier Argenteuil
Argenteuil, 95107, France
Centre Hospitalier D'Avignon
Avignon, 84000, France
CH Beziers
Béziers, 34500, France
Institut Bergonie
Bordeaux, 33076, France
Cabinet D'hematologie De La Clinique Du Parc
Castelnau-le-Lez, 34170, France
CH William Morey
Chalon-sur-Saône, 71321, France
CH Chambery
Chambéry, 73000, France
CHU Estaing Clermont Ferrand
Clermont-Ferrand, 63003, France
CHU Dijon, François Mitterrand
Dijon, 21000, France
Centre Hospitalier De Dunkerque
Dunkirk, 59240, France
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, 85000, France
CH De Versailles (Andre Mignot)
Le Chesnay, 78157, France
Hopital Bicetre
Le Kremlin-Bicêtre, 94270, France
CH De Libourne
Libourne, 33505, France
CHRU De Lille - Hôpital Huriez
Lille, 59037, France
CH Limoges
Limoges, 87042, France
Leon Berard, Lyon
Lyon, 69373, France
Centre Hospitalier De Meaux
Meaux, 77100, France
Hopitaux Prives Metz Centre De Belle-Isle
Metz, 57000, France
CH De Metz (Hopital De Mercy - CHR Metz Thionville)
Metz, 57530, France
CHU Montpellier
Montpellier, 34090, France
Hopital Salpetriere
Paris, 75013, France
La Pitié Salpêtrière - Paris
Paris, 75013, France
Hopital Necker
Paris, 75015, France
CH St Jean
Perpignan, 66000, France
CHU De Poitiers
Poitiers, 86021, France
Hôpital Rene Dubos
Pontoise, 95300, France
CH De Cornouaille
Quimper, 29107, France
CHU De Rennes
Rennes, 35033, France
Hopital Victor Provo
Roubaix, 59056, France
La Clinique Sainte-Anne
Strasbourg, 67000, France
CHRU Strasbourg
Strasbourg, 67200, France
Institut Universitaire Du Cancer Toulouse - Oncopo
Toulouse, 31059, France
CH Troyes
Troyes, 10000, France
CHRU De Nancy - Hôpitaux De Brabois
Vandœuvre-lès-Nancy, 54511, France
CHU Sud, St Pierre - La Réunion
Vandœuvre-lès-Nancy, 54511, France
Related Publications (1)
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.
PMID: 39506529DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali G. Turnan, MD, PhD
Paris Sud University Hospitals-Bicetre
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 7, 2019
Study Start
February 23, 2018
Primary Completion
December 31, 2022
Study Completion
July 3, 2023
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share