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
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.
Observational Model: Case-Only, Time Perspective: Prospective
At one year from study entry
Giuseppe SAGLIO, Pr.
Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
Italy: Ethics Committee