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Clinical Trials/EUCTR2010-019568-35-FR
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

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.

Registry
who.int
Start Date
May 6, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CH VERSAILLES

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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