Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response

Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cytogenetic Response for at Least One Year

The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.

The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. This study aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.

Inclusion Criteria:

1. Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,
2. Patients in complete cytogenetic response for at least 1 year
3. Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)
4. ECOG ≤ 2,
5. Age ≥ 18 years
6. Signed informed consent,
7. Membership of a social security system

Exclusion Criteria:

1. Patients with CML-CP Philadelphia chromosome negative diagnosis.
2. Patients previously treated with Imatinib Mesylate at doses above 400 mg / day
3. Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg / d
4. Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment
5. Pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective
6. Known HIV positive
7. Patients previously treated with another tyrosine kinase inhibitor
8. Patient participating in another interventional clinical trial
9. History of non-compliance to Imatinib Mesylate