CML and Ph MedDRA version: 6.1 Level: PT Classification code 10000880
Conditions
Interventions
Trade Name: Dasatinib
Product Name: DASATINIB
Product Code: BMS354825
Pharmaceutical Form: Tablet
Current Sponsor code: BMS 354825
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: adults more than 18 yeras affected with all phases of CML Chronic, accelerated and blast phase and Ph ALL with demostrated Imatinib resistance or intolerance. Patients with Ph ALL, must have also progressed after receiving at least one induction-consolidation chemotherapy regimen. Total bilirubin equal to 2.0 times the institutional upper limit of normal; ALT e AST equal to 2.5 times the institutional upper limit of normal; serum creatinine equal to 3.0 times the institutional upper limit of normal 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: Imatinib treatment efficacy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to make Dasatinib available for those patients who have failed the Imatinib treatment and for those it is not usefull another kind of therapy;Secondary Objective: N.D.;Primary end point(s): rendere il Dasatinib disponibile per quei pazienti che hanno fallito il trattamento con Imatinib e per i quali non e piu possibile costruire una terapia efficace con i farmaci in commercio. | — |
Countries
Italy
Outcome results
None listed