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Clinical Trials/EUCTR2008-006854-17-FR
EUCTR2008-006854-17-FR
Active, not recruiting
Phase 1

A PROSPECTIVE RANDOMIZED PHASE II STUDY EVALUATING THE OPTIMIZATION OF THE RESIDUAL PLASMATIC LEVEL OF DASATINIB (SPRYCEL®) IN PATIENTS NEWLY DIAGNOSED WITH CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML). - OPTIM DASATINIB

CH-Versailles0 sites130 target enrollmentMarch 17, 2009
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DrugsSPRYCEL

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
CH-Versailles
Enrollment
130
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 17, 2009
End Date
TBD
Last Updated
5 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\.ECOG Performance Status score 0\-2
  • •3\.Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (\= 3 months) in chronic phase.
  • •4\.Not previously treated except with hydroxyurea
  • •5\.Signed written inform consent
  • •6\.Adequate hepatic function defined as: total bilirubin \= 2\.0 times the institutional ULN; ALT and AST \= 2\.5 times the institutional upper limit of normal (ULN).
  • •7\.Adequate renal function defined as serum creatinine \= 3 times the institutional ULN.
  • •8\.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:

Exclusion Criteria

  • •1\.Patients with BCR\-ABL positive, Philadelphia negative CML
  • •2\.Patient previously treated with TKI
  • •3\.Pregnancy
  • •4\.Active malignancy
  • •5\.Uncontrolled or significant cardiovascular disease
  • •6\.Patients with QTc \> 450 ms
  • •7\.Significant bleeding disorder unrelated to CML
  • •8\.Concurrent severe diseases which exclude the administration of therapy

Outcomes

Primary Outcomes

Not specified

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