Chronic myeloid leukemia MedDRA version: 14.1 Level: LLT Classification code 10052065 Term: Chronic phase chronic myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration number: 800-
Sponsors
AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Aged < 18 years. No signed informed consent. Diagnosis of any other form of leukemia except from chronic myeloid leukemia. E.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the frequency of the polimorfisms of the genes involved in the intracellular uptake of Nilotinib in caucasian patients.;Secondary Objective: 1) To establish a possible association between the polimorfisms of the genes involved in the intracellular uptake of Nilotinib and the pathogenesis and progression of chronic myeloid leukemia. 2) To establish a possible association between the polimorfisms of the genes involved in the intracellular uptake 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 population | — |
Countries
Italy
Contacts
Public Contactinfo sulla sperimentazione
Hematology clinical trial
Outcome results
None listed