Imatinib Concentration Monitoring Evaluation (I-COME)

In collaboration with several Swiss University and Cantonal Hospital Centers, we currently evaluate, for all Swiss CML patients treated with imatinib since < 5 years, the monitoring of their imatinib plasma levels (i.e. therapeutic drug monitoring, TDM). This service is offered in relation with a prospective study:

• Imatinib concentration monitoring is currently recommended in case of clinical problems with the treatment, i.e. insufficient therapeutic response or toxic side effects ("Rescue"-TDM).
• What our study adds is to offer patients, on a randomized basis, a preventively designed "Routine"-TDM in the absence of clinical concerns regarding the treatment.

Therefore we would like to invite all Swiss hematologists to have imatinib plasma concentration of their CML patients monitored in the scope of this study. Besides providing TDM service to all patients with clinical concerns regarding treatment, it will also contribute to assess the best strategy for imatinib TDM, i.e. preventive versus reactive.

Approval

The study has been approved from the local Ethics Committee in the following Swiss cantons:
AG, AI, BE, BS/BL, FR, GE, GL, GR, JU, LU, NE, NW/OW, SG, SH, SO, SZ, TI, TG, UR, VD, VS, ZH, ZG.

It has also been approved in the Principality of Liechtenstein (LI).

Trial registration

ISRCTN31181395, EudraCT 2009-011519-19, European LeukemiaNet Trial Registry

Financial support

Centre Hospitalier Universitaire Vaudois (study sponsor) – Novartis (grant in aid)

Further information:

• Why monitoring imatinib in the scope of a study?
• Practical study information
• Study related documents
• Contact & investigators