Status:
COMPLETED
TyrosIne Kinase Inhibitors in Chronic Myeloid Leukemia: Efficacy and Tolerability. The TIKlet Study
Lead Sponsor:
University of Pisa
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-80 years
Brief Summary
Rationale The pharmacokinetics of imatinib and nilotinib, two BCR/Abl tyrosine-kinase inhibitors (TKI), is variable among patients suffering from chronic myeloid leukemia (CML). Transmembrane transpo...
Detailed Description
1\. Patients 1.1. Patients CML patients will be included according to the following inclusion criteria: a) patients of both sexes, b) age between 18 and 80 years, c) treated with imatinib or nilotin...
Eligibility Criteria
Inclusion
- Patients affected by chronic myeloid leukemia
- Age limits: 18-80 years
- Male and female patients
- Treatment with imatinib/nilotinib since at least 3 weeks
- Optimal adherence
- Signed informed consent
Exclusion
- Age \<18 or \>80 years
- Poor adherence
- Inability to attend follow-up visits
- Lack of signed informed consent
- Concomitant administration of other drugs will be allowed, but active pharmacological agents, their dose and duration of treatment should be recorded.
- Smoking is not considered an exclusion criterium, but it should be noticed and recorded
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT01860456
Start Date
May 1 2013
End Date
December 31 2024
Last Update
June 5 2025
Active Locations (2)
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1
Unit of Hematology, Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
2
Division of Hematology and Transplants, University of Siena
Siena, Italy, 53100