EUCTR2010-019568-35-FR
Active, not recruiting
Not Applicable
A prospective randomized phase II study evaluating the monitoring of imatinib mesylate (Gliveec®) plasmatic through level in patients newly diagnosed with chronic phase chronic myelogenous leukaemia (CP-CML). - OPTIM IMATINIB
CH VERSAILLES0 sitesMay 6, 2010
DrugsGLIVEC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Phase Chronic myelogenous leukemia (CP CML)
- Sponsor
- CH VERSAILLES
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female patient \= 18 years
- •2\.Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (\= 4 months) in first chronic phase.
- •3\.Not previously treated with tyrosine kinase inhibitors other than imatinib
- •4\.Prior treatment with imatinib during less than 6 weeks
- •5\.Signed written inform consent
- •6\.Women of childbearing potential (WOCBP) must be using an adequate method of contraception
- •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
Exclusion Criteria
- •1\.Patients with BCR\-ABL positive, Philadelphia negative CML
- •2\.Patient previously treated with TKI other than imatinib
- •3\.Pregnancy
- •4\.Active malignancy
- •5\.Concurrent severe diseases which exclude the administration of therapy
Outcomes
Primary Outcomes
Not specified
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