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

Institut Bergonié

Status and phase: Terminated; Phase 3

Conditions: Leukemia, Myeloid, Chronic-Phase

Treatments: Drug: Imatinib Mesylate 600 MG Oral Tablet; Drug: Imatinib Mesylate 400 MG Oral Tablet; Drug: Imatinib Mesylate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01827930

IB2009-07

2008-007094-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

Imatinib 600 (Randomized trial)

Experimental group

Description:

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

Treatment:

Drug: Imatinib Mesylate 600 MG Oral Tablet

Imatinib 400 (Randomized trial)

Active Comparator group

Description:

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

Treatment:

Drug: Imatinib Mesylate 400 MG Oral Tablet

Imatinib400 (Cohort)

Other group

Description:

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

Treatment:

Drug: Imatinib Mesylate