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lack of interest
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This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.
This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CML ph+ patients | Chronic myeloid leukemia patients who are philadelphia positive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ponatinib | Drug | Observation of tolerability and safety profiles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | General adverse events and grade 3-4 adverse events according to NCI CTCAE version 4.0 | Maximum of 60 months from treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with hematological complete response | Hematological complete response and related responses, such as major cytogenetic response, complete cytogenetic response and major molecular response. | Maximum of 60 months from treatment start |
| Number of days from treatment start till response |
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Inclusion Criteria:
Exclusion Criteria:
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CML Ph+ patients in the Ponatinib compassionate use program
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Fava | Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 - Orbassano | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro | Bari | Italy | ||||
| IRCCS_AOU San Martino-IST.Clinica Ematologica |
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| Label | URL |
|---|---|
| GIMEMA Foundation website | View source |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C545373 | ponatinib |
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| Maximum of 60 months from treatment start |
| Total number of patients alive | Overall survival | 12 months after patient enrollment in the study |
| Number of patients in event free survival | Event free survival | 12 months after patient enrollment in the study |
| Number of patients in progression free survival | Progression free survival | 12 months after patient enrollment in the study |
| Number of mutations | Both at the beginning and at the end of treatment | Maximum of 60 months from treatment start |
| Number of units of Ponatinib administered per units of time | Chemotherapy dose intensity represents unit dose of chemotherapy administered per unit time. | Maximum of 60 months from treatment start |
| Genova |
| Italy |
| ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE | Lecce | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano | Milan | Italy |
| Azienda Ospedaliera "S.Gerardo" | Monza | Italy |
| S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | Novara | Italy |
| Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 - Orbassano | Orbassano | Italy |
| S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo | Pavia | Italy |
| Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" | Reggio Calabria | Italy |
| U.O.C. Ematologia - Ospedale S. Eugenio | Roma | Italy |
| 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 |