An extension to a phase II study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome-positive leukemia including acute lymphoblastic leukaemia, acute myeloid leukaemia, and accelerated phase chronic myeloid leukemia - N/A
Phase 1
- Conditions
- Philadelphia chromosome-opositive chronic myeloid leukamia in myeloid blast crisis
- Registration Number
- EUCTR2004-001396-19-GB
- Lead Sponsor
- ovartis Pharmaceuticals UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 293
Inclusion Criteria
As for original protocol
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
AS for original protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: •To enable patients to have access to study drug and continue study treatment<br> •To decrease data collection to include overall survival and serious adverse events<br> ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method