An extension to a phase II study to determine the safety and the anti- leukemic effects of STI571 in adults patients with Philadelphia chromosome positive leukemia including acute lymphoblastic leukemia, acute myeloid leukemia and accelerate phase myeloid leukemia.
- Conditions
- Philadelphia chromosome positive leukemia including acute lymphoblastic leukemia, acute myeloid leukemia and accelerate phase myeloid leukemia.MedDRA version: 14.1Level: HLTClassification code 10024296Term: Leukaemias chronic myeloidSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-001381-14-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 294
Inclusion Criteria
Refer to the original protocol for details of overall study design.
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
Refer to the original protocol for details of overall study design.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ? To enable patients to have access to study drug and continue study treatment ? To decrease data collection to include only overall survival and serious adverse events;Secondary Objective: NA;Primary end point(s): Overall survival
- Secondary Outcome Measures
Name Time Method