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Leukemia, Myeloid

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Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

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Myeloid Leukemia

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Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

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Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

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Tyrosine

Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po

Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po

Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po

Imatinib Mesylate 600 MG Oral Tablet

Imatinib Mesylate 400 MG Oral Tablet

ETIENNE Gabriel, MD

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.

IM concentration \< 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration \>= 1000ng/mL Parallel Cohort: "standard strategy"

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 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.

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).

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

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.

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.

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

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).

Novartis

Institut Bergonié

All adverse envent (related and unrelated to treatment) were reported.

All serious adverse envent (related and unrelated to treatment) were reported.

Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po

Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML

Imatinib 600 (Randomized Trial)

Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po

Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML

Imatinib 400 (Randomized Trial)

Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po

Imatinib Mesylate: Imatinib Mesylate for CP CML

Imatinib400 (Parallel Cohort)

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

France

Region of Enrollment

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response	NCT01827930	Leukemia, Myelo...	Imatinib Mesyla... Imatinib Mesyla... Imatinib Mesyla...	18 Years -	Institut Bergonié
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response	NCT01827930	Leukemia, Myelo...	Imatinib Mesyla... Imatinib Mesyla... Imatinib Mesyla...	18 Years -	Institut Bergonié

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