Imatinib Concentration Monitoring Evaluation (I-COME)

In collaboration with several Swiss University and Cantonal Hospital Centers, the monitoring of their imatinib plasma levels (i.e. therapeutic drug monitoring, TDM) was evaluated for all Swiss CML patients treated with imatinib since < 5 years. This service was 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 added was to offer patients, on a randomized basis, a preventively designed "Routine"-TDM in the absence of clinical concerns regarding the treatment.

Results from this study will soon be available.

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).

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

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