Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib
- Registration Number
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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.
- Patients less than 18 year old.
- Use of Nilotinib as first line treatment.
- Patients treated with Nilotinib before 2005.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study cohort group Imatinib 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.
- Primary Outcome Measures
Name Time Method Overall Survival At one year from study entry
- Secondary Outcome Measures
Name Time Method Rate of complete haematologic remission t At one year from study entry Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses.
Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death 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 At one year from study entry Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses.
Rate of compete cytogenetic response At one year from study entry Rate of complete cytogenetic response with Nilotinib treatment and the duration of the responses.
Rate of major molecular remission At one year from study entry Rate of major molecular remission with Nilotinib treatment and the duration of the responses.
Trial Locations
- Locations (28)
Centro Oncologico Basilicata
🇮🇹Rionero in Vulture, Potenza, Italy
Ospedale
🇮🇹Taranto, Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
S.G. Moscati Hospital
🇮🇹Avellino, 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
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