Phase III,multicentre,open-label,prospective randomised trial comparing Imatinib alone at 400mg versus 800mg daily versus Imatinib 400mg daily plus PEG Interferon-alpha with newly diagnosed chronic myeloid leukaemia - Spirit
Phase 1
- Conditions
- Chronic Myeloid Leukaemia (Chronic Phase)
- Registration Number
- EUCTR2004-001622-24-IE
- Lead Sponsor
- ewcastle Hospital Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 259
Inclusion Criteria
Within 3 months of initial diagnosis of chronic myeloid leukaemia in chronic phase
Previously intreated with the exception of hydroxyurea and/or anagrelide
Cytogenetic confirmation of Philadelphia chromosome or variants of (9;22) translocations
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
Patients with PH-negative,BCR-ABL positive disease are NOT eligible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine overall survival at 5 years;Secondary Objective: To determine the molecular response at 1 year;Primary end point(s): To determine overall survival at 5 years
- Secondary Outcome Measures
Name Time Method