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Spots Global Cancer Trial Database for Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib

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Trial Identification

Brief Title: Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib

Official Title: Observational Study in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia (CML) Treated With Nilotinib: Follow-up of the Italian Patients. GIMEMA Study CML0609

Study ID: NCT01475110

Interventions

Imatinib

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centro Oncologico Basilicata, Rionero in Vulture, Potenza, Italy

Ospedale, 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, , Italy

Ospedale Ferrarotto, Catania, , Italy

Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna, Ferrara, , Italy

Policlinico di Careggi, Università delgi studi di Firenze, Firenze, , 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, , Italy

A.O. Universitaria Policlinico Martina di Messina, Messina, , Italy

U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele, Milano, , Italy

Federico II, Napoli, , Italy

Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, Orbassano, , Italy

Azienda Ospedaliera di Padova, Padova, , Italy

Ospedale Cervello, Palermo, , 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, , Italy

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy

U.O. Ematologia, Azienda Ospedaliera Universitaria Senese, Siena, , Italy

Ospedale, Taranto, , Italy

SCDO Ematologia 2 AOU S. Giovanni Battista, Torino, , Italy

Policlinico Universitario - Clinica Ematologia, Udine, , Italy

Policlinico G. B. Rossi - Borgo Roma, Verona, , Italy

Contact Details

Name: Giuseppe SAGLIO, Pr.

Affiliation: Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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