The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Giuseppe SAGLIO, Pr.
Affiliation: Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
Role: PRINCIPAL_INVESTIGATOR