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

• Conditions: Chronic Phase Chronic myelogenous leukemia (CP CML)

• Registration Number: EUCTR2010-019568-35-FR
• Lead Sponsor: CH VERSAILLES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified