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The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment will include all patients who started Nilotinib between January 2005 and December 2012. Patients will be followed for 4 years since treatment start. After this time, survival data, disease status and treatment will be recorded at 6-months-interval. This study will help the definition of guidelines for a proper management of Nilotinib in any-phase CML patients.
Follow-up is required until the end of treatment for the purposes of the study for all patients by standard hematologic, cytogenetic and molecular criteria. This study will not contemplate any additional expense beyond what is expected for a regular follow-up, according to the international guidelines for CML.
Sample Size: target accrual was not defined, all eligible patients observed between January 2005 and December 2012 will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort group | Adult patients with Imatinib resistant (failure + suboptimal) or intolerant chronic myeloid leukaemia in all phases, who started treatment with Nilotinib between January 2005 and December 2012 in Italy. Adult pts treated with Nilotinib as second line therapy after Dasatinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib | Drug | Observation of Imatinib resistant patients treated with Nilotinib. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | At one year from study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete haematologic remission t | Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses. | At one year from study entry |
| Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death |
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Inclusion Criteria:
Exclusion Criteria:
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The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollement will include all patients who started Nilotinib between January 2005 and December 2012.
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe SAGLIO, Pr. | Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Oncologico Basilicata | Rionero in Vulture | Potenza | Italy | |||
| Ospedale |
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| Label | URL |
|---|---|
| GIMEMA Foundation Website | View source |
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| At one year from study entry |
| Event Free Survival (EFS) | At one year from study entry |
| Progression Free Survival (PFS) | At one year from study entry |
| Rate of point mutations before or after Nilotinib treatment | At one year from study entry |
| Rate of major cytogenetic response | Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses. | At one year from study entry |
| Rate of compete cytogenetic response | Rate of complete cytogenetic response with Nilotinib treatment and the duration of the responses. | At one year from study entry |
| Rate of major molecular remission | Rate of major molecular remission with Nilotinib treatment and the duration of the responses. | At one year from study entry |
| Alessandria |
| Italy |
| S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Italy |
| S.G. Moscati Hospital | Avellino | Italy |
| Ospedale | Bari | Italy |
| Ospedale | Bologna | Italy |
| Azienda Spedali Civili | Brescia | 25100 | Italy |
| Ospedale Ferrarotto | Catania | Italy |
| Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna | Ferrara | 44100 | Italy |
| Policlinico di Careggi, Università delgi studi di Firenze | Florence | Italy |
| Clinica Ematologica - Università degli Studi | Genova | Italy |
| Università degli Studi | Genova | Italy |
| Università di Genova | Genova | Italy |
| ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia | Lecce | 73100 | Italy |
| A.O. Universitaria Policlinico Martina di Messina | Messina | Italy |
| U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele | Milan | 20132 | Italy |
| Federico II | Naples | Italy |
| Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10 | Orbassano | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Ospedale Cervello | Palermo | 90146 | Italy |
| Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone | Palermo | Italy |
| Dipartimento Oncologico - Ospedale S.Maria delle Croci | Ravenna | Italy |
| Ospedale | Reggio Calabria | Italy |
| Ospedale | Rimini | Italy |
| U.O. di Ematologia - Centro Oncologico Basilicata | Rionero in Vulture | Italy |
| Ematologia - Sapienza Università di Roma | Roma | Italy |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | 00168 | Italy |
| Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy |
| U.O. Ematologia, Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| Ospedale | Taranto | Italy |
| SCDO Ematologia 2 AOU S. Giovanni Battista | Torino | Italy |
| Policlinico Universitario - Clinica Ematologia | Udine | 33100 | Italy |
| Policlinico G. B. Rossi - Borgo Roma | Verona | 37134 | Italy |
| 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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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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