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

The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Treatment is considered effective at 12 months if: * for patients with an inclusion transcript rate less than 0.1%: the transcript rate at 12 months is less or equal to 0.001% or undetectable. * for patients with an inclusion transcript rate greater than 0.1% : the transcript rate at 12 months is less or equal to 0.1% or undetectable. If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective.

Time frame: 12 months

Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.

The molecular response is defined by the measurement of BCR-ABL transcript rate by quantitative RT-PCR (RQ-PCR) on peripheral venous blood according to international standards. It is defined as: * Major Molecular Response (MMR): BRC-ABL transcript rate ≤ 0.1% * Complete Molecular Response (CMR): transcript BCR-ABL undetectable and non quantifiable.

Time frame: 3, 6, 9 and 12 months

Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.

Overall survival is defined by the time from de date of inclusion/randomization to the date of death (of any cause).

Time frame: First 12 months

Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.

Progression-free survival was defined by the time from the date of inclusion and the date of progression. Progression was defined as : * Death, * Passage into the acceleration phase defined by one of the following criteria: % of blood or medullary blasts greater than 15% but less than 30%, blasts plus promyelocytes greater than 30% in the blood or marrow, basophils greater than 20% in the blood, thrombocytopenia less than 100x10\^9/L unrelated to treatment, clonal evolution) * Passage to the blast transformation phase defined by one of the following criteria: % of blasts of blood or bone marrow greater than 30%, occurrence of extramedullary damage other than histologically proven hepato-splenic. * Increase in BCR-ABL transcripts greater than or equal to 2-log compared to the previous values (this increase must be confirmed within 3 months).

Time frame: First 12 months

Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.

The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months.

Time frame: 12 first months

Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.

The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Efficacy was also evaluated at 3, 6, 9 and 12 months in terms of decreasing the rate of BCR-ABL transcripts of 2 logarithms, relative to the initial value (inclusion). The lack of data on the transcript rate was considered as failure (no decrease).

Time frame: 3, 6, 9 and 12 months

Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.

Time to complete molecular response was defined by the time from inclusion/randomization and the first CMR.

Time frame: From date of randomization until the date of complete molecular response (up to 12 months)

Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.

The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Time to the first BCR-ABL undetectable was defined by the time from inclusion/randomization and the first CMR.

Time frame: within 12 months following randomization

Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.