Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Myeloid Leukaemia

Intervention / Treatment
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* Drug: Imatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study cohort group<br>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. | Drug: Imatinib<br>* Observation of Imatinib resistant patients treated with Nilotinib.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | At one year from study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete haematologic remission t | Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses. | At one year from study entry | 
| 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 | Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses. | 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. | 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. | At one year from study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imatinib resistant, Imatinib, Chronic Myeloid Leukaemia, Nilotinib, Adult patients