Patients affected by TET or LCH
Conditions
Interventions
Trade Name: GLIVEC*120CPS 100MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IMATINIB MESILATO
CAS Number: 220127-57-1
Concentration unit: mg/g milligram(s)/gram
Concentration type: e
Sponsors
UNIVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 2. TET or LCH confirmed by istological analisys 3. Patients that have received at least one line of treatment with progression of disease 4. Immunoistochemical evaluation expression of cKIT, PDGFRα, PDGFRβ, m-TOR, p-AKT in LCH patints , expression of EGFR, c-KIT, COX-in TET patients. 5. Age from 18 to 75 years old Are the trial subjects under 18? no Number of subjects for this age range: 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: 1. Pregnat womeni, childbearing or in fertile period without anticonceptional measures 2. Non measurable lesion as unique site of disease 3. Important disease that can give at the patient high risk of injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the efficacy of treatment with imatinib mesylate in patients affected by refractory TET or LCH. Evaluation of activity will be based on complete pathological response (according to RECIST criteria).;Secondary Objective: 2. Evaluation of safety and toxicity (according to NCI criteria), quality of life (according to EORTC QLQ-C30). 3. Identification of predictive biological markers of clinical response: pharmacogenomic and immunological parameters.;Primary end point(s): Determine the efficacy of treatment with imatinib mesylate in patients affected by refractory TET or LCH. Evaluation of activity will be based on complete pathological response (according to RECIST criteria). | — |
Countries
Italy
Outcome results
None listed