Chronic myeloid leukaemia (CML) Cancer Myeloid leukaemia
Conditions
Interventions
Each patient will achieve a one-year study period while being included in one of the two following groups:
Intervention arm:
A systematic monitoring of imatinib plasma concentrations will be perform
Sponsors
University Hospital Centre and University of Lausanne (CHUV) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. CML patients in the chronic or accelerated phase of the disease 2. Receiving imatinib since less than 5 years 3. Aged 18 years and older, either sex
Exclusion criteria
Exclusion criteria: 1. Pregnant and breastfeeding women are excluded de facto from this study 2. Less than 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients remaining without lack of efficacy or disease progression (i.e. "event-free" according to IRSI study definition) 2. Occurrence of moderate or severe adverse events (NCI-CTC grade 2 or more oedema, fatigue, headache, nausea, diarrhoea, musculoskeletal pain and skin rash; grade 3 or more anaemia, neutropenia, thrombocytopenia and increased liver enzymes; leucopenia and vomiting will not be analysed because of their obvious correlation with neutropenia and nausea) 3. Discontinuation of treatment Measured after one-year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients achieving major molecular response (MMR) after one-year follow-up 2. Median reduction of BCR-ABL transcripts (i.e. molecular response) over one year 3. Percentage of patients achieving complete cytogenetic response (CCyR) after one-year follow-up 4. Percentage of patients remaining without moderate adverse events of any kind (NCI-CTC grade 2) 5. Percentage of patients with clinical concerns at inclusion (i.e. lack of response/progression or adverse events) and presenting an improvement over one year 6. Percentage of patients with imatinib plasma levels above 1000 ng/ml after one-year follow-up 7. Predictive performance of either total or free concentrations for the achievement of therapeutic outcomes or the occurrence of concentration-related adverse effects (PK-PD relationships using all collected samples) 8. Interaction of genetic factors or co-medication known to affect drug transport (P-gp and hOCT1) and metabolism (CYP3A) with pharmacokinetic variables and efficacy/toxicity outcomes 9. Compliance of practitioners towards dosage adaptation advice | — |
Countries
Switzerland
Outcome results
None listed