TyrosIne Kinase Inhibitors in Chronic Myeloid Leukemia: Efficacy and Tolerability. The TIKlet Study

Plain-language summary

This study examined the efficacy and tolerability of the tyrosine kinase inhibitor drugs Imatinib/Nilotinib in patients with chronic myeloid leukemia. It included patients aged 18-80 who had been treated with imatinib or nilotinib for at least 3 weeks. The study was carried out as a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

University of Pisa

Intervention

Imatinib/Nilotinib

Start date

5/1/2013

Estimated completion

12/31/2024

Countries

Italy

Related genes

Locations

• Pisa, Italy
• Siena, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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 Criteria:

* 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