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

Phase 3TerminatedNCT01827930

Institut Bergonié68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

Imatinib Mesylate 600 MG Oral TabletDRUG

Imatinib Mesylate for CP CML

Imatinib Mesylate 400 MG Oral TabletDRUG

Imatinib Mesylate for CP CML

Imatinib MesylateDRUG

Imatinib Mesylate for CP CML

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Bergonié

Bordeaux, Aquitaine, France

Outcomes

Primary Outcomes

Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study

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

Secondary Outcomes

Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study

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

Molecular Response at 3, 6, 9 and 12 Months

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

Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR)

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.