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.
Study Type
OBSERVATIONAL
Enrollment
19
Observation of Imatinib resistant patients treated with Nilotinib.
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
Overall Survival
Time frame: At one year from study entry
Rate of complete haematologic remission t
Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses.
Time frame: At one year from study entry
Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death
Time frame: At one year from study entry
Event Free Survival (EFS)
Time frame: At one year from study entry
Progression Free Survival (PFS)
Time frame: At one year from study entry
Rate of point mutations before or after Nilotinib treatment
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At one year from study entry
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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
Florence, Italy
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