Chronic Phase Chronic myelogenous leukemia (CP CML)
Conditions
Interventions
Trade Name: GLIVEC
Product Name: IMATINIB MESYLATE
Pharmaceutical Form: Tablet
Sponsors
CH VERSAILLES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient = 18 years 2. Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (= 4 months) in first chronic phase. 3. Not previously treated with tyrosine kinase inhibitors other than imatinib 4. Prior treatment with imatinib during less than 6 weeks 5. Signed written inform consent 6. Women of childbearing potential (WOCBP) must be using an adequate method of contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with BCR-ABL positive, Philadelphia negative CML 2. Patient previously treated with TKI other than imatinib 3. Pregnancy 4. Active malignancy 5. Concurrent severe diseases which exclude the administration of therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evalutate the efficacy and the feasibility of the adaptation of imatinib daily dose based on imatinib mesylate (Gleevec®, Laboratoires Novartis Pharma) plasmatic trough level in term of major molecular response at 12 months. ;Primary end point(s): a. The major molecular response rate at 12 months in cohort 1. ;Secondary Objective: To evaluate the cumulative rate of major cytogenetic response at 6 and12 months. To evaluate the cumulative rate of complete cytogenetic response at 6 and 12 months To evaluate the cumulative rate of complete molecular response at 3, 6, 9 and 12 months To evaluate the time to molecular response (major or complete) in each cohort To evaluate the tolerance of optimized imatinib therapy. To evaluate overall survival, progression free survival and event free survival at 5 years. To evaluate intra patient variations of imatinib dosage To correlate the imatinib trough level to the daily dose of imatinib To evaluate the impact of imatinib metabolites on efficacy and tolerance | — |
Countries
France
Outcome results
None listed