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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants in CP-CML phase who achieved complete hematologic response | CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia. | from 24-60 months |
| Proportion of participants in AP and BP phases who achieved major (complete + partial) cytogenetic response |
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Inclusion Criteria:
Exclusion Criteria:
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70 public and private French investigative centers of hematology will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Ali G. Turnan, MD, PhD | Paris Sud University Hospitals-Bicetre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU SUD Reunion GHSR | Saint-Pierre | Reunion | 97410 | France | ||
| CHU Amiens-Picardie- Site SUD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39506529 | Derived | 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. |
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CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia. |
| from 24-60 months |
| Proportion of participants who achieved major molecular response and/or depth molecular response: (MR4 or MR4.5 or MR5) | CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia. | from 24-60 months |
| Duration of response | Duration of CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia. | from 24-60 months |
| Time to progression to AP-CML or BP-CML (for those participants not in AP-CML or BP-CML) | Time to progression to AP-CML defined as follows: Blasts in blood or marrow 15%-29%, or blasts plus promyelocytes in blood or marrow > 30%, with blasts < 30%; basophils in blood ≥ 20%; persistent thrombocytopenia (< 100 × 10^9/L) unrelated to therapy; clonal chromosome abnormalities in Ph1 cells (CCA/Ph1), major route, on treatment. Time to progression to BP-CML defined as follows: Blasts in blood or marrow ≥ 30%; extramedullary blast proliferation, apart from spleen. | from 24-60 months |
| Dose reduction (after response) in each cohort | Includes level of response at the time of dose reduction and maintenance of response after dose reduction. | from 24-60 months |
| Time to response | Time to CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia. | from 24-60 months |
| Rate of progression to accelerated phase (AP-) or blast phase (BP-) CML | Rate of progression to AP- or BP-CML as defined in European LeukemiaNet (ELN) criteria. | from 24-60 months |
| Progression-free survival (PFS) | Survival without any progression to AP or BP according to ELN criteria. | from 24-60 months |
| Overall survival (OS) | Overall survival defined according to ELN criteria. | from 24-60 months |
| Rate of adverse events | Adverse event is any untoward medical occurrence in a patient or clinical study subject administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. | from 24-60 months |
| Rate of discontinuation due to adverse events in each dose cohort | Adverse event is any untoward medical occurrence in a patient or clinical study subject administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. | from 24-60 months |
| Dose reductions (prior to response) in each dose cohort | Reduction in the dose of Iclusig. | from 24-60 months |
| Dose interruptions in each dose cohort | Interruption of Iclusig treatment. | from 24-60 months |
| 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 |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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