Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib (CML0609)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Completed

Conditions: Chronic Myeloid Leukaemia

Treatments: Drug: Imatinib

Study type: Observational

Funder types: Other

Identifiers

NCT01475110

CML0609

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

19 participants in 1 patient group

Study cohort group

Description:

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.

Treatment:

Drug: Imatinib