US Patent:
20110224224, Sep 15, 2011
Inventors:
Yanfeng Wang - East Hanover NJ, US
Thea Kalebic - East Hanover NJ, US
Timothy Peter Hughes - South Australia, AU
Deborah White - South Australia, AU
International Classification:
A61K 31/506
A61P 35/02
Abstract:
The present invention relates to a method of treating Philadelphia-positive leukemia (Ph+ leukemia), in a particular chronic myeloid leukemia (CML), in a human patient population. More specifically, the present invention pertains to a method of treating Ph+ leukemia, such as CML or Ph+ ALL, in a human patient suffering from Ph+ leukemia comprising the steps of(a) administering a predetermined fixed amount of Imatinib as a free base or in the form of a pharmaceutically acceptable salt thereof to the human patient,(b) collecting at least one blood sample from the patient, e.g. within the first 12 months of treatment,(c) determining the plasma trough level (Cmin) of Imatinib,(d) determining the OCT-1 Activity in the blood sample, and(e) adjusting the dose of Imatinib applied to the individual patient in a manner that an Imatinib Cmin value is achieved in the patient of at least 800 ng/mL, if in step (c) an Imatinib Cmin value of less than 800 ng/mL is found and in step (d) an OCT-1 Activity is found below 6.0 to 10.0 ng/200,000 cells.
