Clinical trial NCT01827930: Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Leukemia, Myeloid, Chronic-Phase
Keywords: chronic myeloid leukemia in chronic phase
residual plasma IM concentration
adapted strategy
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2013-04-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: IM concentration \< 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration \>= 1000ng/mL Parallel Cohort: "standard strategy"
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study
timeFrame: 3, 6, 9 and 12 months
measure: Molecular Response at 3, 6, 9 and 12 Months
timeFrame: 3, 6, 9 and 12 months
measure: Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR)
timeFrame: From date of randomization until the date of complete molecular response (up to 12 months)
measure: Rate of BCR-ABL Undetectable
timeFrame: 12 first months
measure: Time to the First BCR-ABL Undetectable
timeFrame: within 12 months following randomization
measure: Overall Survival
timeFrame: First 12 months
measure: Progression-free Survival
timeFrame: First 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
Study officials:
affiliation: Institut Bergonié
name: ETIENNE Gabriel, MD
role: STUDY_CHAIR
References: