AN OBSERVATIONAL STUDY ON THE MOLECULES INVOLVED IN THE INTRACELLULAR UPTAKE IN PATIENTS AFFECTED FROM CHRONIC MYELOID LEUKEMIA RECEIVING TIROSINE-KINASE INHIBITORS.”

Active, not recruiting

Conditions: Chronic myeloid leukemia
MedDRA version: 14.1Level: LLTClassification code 10052065Term: Chronic phase chronic myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2011-000637-37-IT

Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Aged > 18 years.
Signed informed consent.
Diagnosis of chronic myeloid leukemia.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Aged < 18 years.
No signed informed consent.
Diagnosis of any other form of leukemia except from chronic myeloid leukemia.
E.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the frequency of the polimorfisms of the genes involved in the intracellular uptake of Nilotinib in<br>caucasian patients.;Secondary Objective: 1) To establish a possible association between the polimorfisms of the genes involved in the intracellular uptake<br>of Nilotinib and the pathogenesis and progression of chronic myeloid leukemia.<br>2) To establish a possible association between the polimorfisms of the genes involved in the intracellular uptake<br>of Nilotinib and the clinical evolution of chronic myeloid leukemia;Primary end point(s): To evaluate the frequency of polimorfisms of the genes involved in intracellular uptake in the caucasian<br>population

Secondary Outcome Measures