Practical study information

Which patients can be included?

Patients are to be included in case of:

• CML in chronic or accelerated phase of the disease;
• imatinib medication since less than 5 years;
• patient's informed consent.

How to perform monitoring?

To include a patient in the study, simply obtain:

• a blood sample (9 ml EDTA-K whole blood, drawn at maximum distance, but at least 4 h after last drug intake);
• a blood measurement request form: (see study documents section);
• copies of patient's response to treatment and laboratory results;
• patient's signed informed consent form (see study documents section).

Shipping costs and material will be covered by our Division.

While plasma level determinations will be performed in Lausanne, the patients will continue to be treated by their own hematologists and will thus have neither to see another doctor, nor to visit a specific study center.

What will occur with the sample?

At time of the receipt of the inclusion sample in our laboratory, the patient will be randomized to one of the following two groups:

• "Routine"-TDM: The inclusion sample will be measured within one week. Observed concentration will be extrapolated to trough level and dose adjustment recommendations will be worked out (using current literature & population pharmacokinetic data).
• "Rescue"-TDM: The inclusion sample will not be measured immediately, but TDM will remain possible anytime in case of clinical problems, such as suboptimal response or suspicion of toxicity.

Altogether, approximately 2-4 blood samples will be requested during the year of patient's follow-up (at least one sample at inclusion and one at study end; further control measurements will be possible in case of dose modifications or clinical problems).

Do not hesitate to contact us in case of further question regarding the practical aspects of this study.

Study duration

Each patient will be followed-up for a period of 1 year (+/- 3 month). The study will last until 2012.

Graphical overview