Chronic Myeloid Leukaemia
Conditions
Keywords
Imatinib, Chronic Myeloid Leukaemia, Nilotinib, Adult patients, Imatinib resistant
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.
Interventions
DRUGImatinib
Observation of Imatinib resistant patients treated with Nilotinib.
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients less than 18 year old. * Use of Nilotinib as first line treatment. * Patients treated with Nilotinib before 2005.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | At one year from study entry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 complete haematologic remission t | At one year from study entry | Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses. |
| 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. |
| Rate of point mutations before or after Nilotinib treatment | At one year from study entry | — |
Countries
Italy
Outcome results
None listed