An extension to a phase II study to determine the efficacy and the safety of STI571 in patients with chronic myeloid leukemia who are refractory to or intolerant of interferon-alpha
Phase 1
- Conditions
- treatment of patients with CML who are refractory to or intolerant of interferon alpha.MedDRA version: 14.1Level: LLTClassification code 10052065Term: Chronic phase chronic myeloid leukaemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-001382-33-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 532
Inclusion Criteria
Refer to original protocol for details of inclusion and exclusion criteria.
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 original protocol for details of inclusion and exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ? To decrease the frequency of bone marrow evaluations to once a year from once every 6 months for all patients who have achieved a complete cytogenetic response. This study objective has been met as of protocol extension 2 amendment 1. ? To enable patients to continue to have access to study treatment ? To decrease data collection after month 48 of the extension phase to include only overall survival and serious adverse events;Secondary Objective: na;Primary end point(s): Overall survival
- Secondary Outcome Measures
Name Time Method