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
- Conditions
- Chronic phase chronic myelogenous leukaemia (CP-CML).
- Registration Number
- EUCTR2008-006854-17-FR
- Lead Sponsor
- CH-Versailles
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
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:
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method