DASATINIB compassionate use - ND

• Conditions: CML and Ph; MedDRA version: 6.1Level: PTClassification code 10000880

• Registration Number: EUCTR2006-003581-34-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

Imatinib treatment efficacy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified