Roy Hogan from
Singapore is in
MMR on 400mg
Gleevec,
diagnosed 2002.
Mike Westland
from Seattle is
PCRU on
400mg Gleevec,
diagnosed 2001.
Gleevec (Imatinib Mesylate)
- The Phase I Gleevec trials started in 1998. 83 patients in chronic
phase after failing Interferon alpha were enrolled. Doses ranged
from 25-1000mg a day and there was a clear dose-response
relationship from the trials. Doses of 750mg a day or more showed
higher side-effects. The 54 patients who took 300mg or more per
day had a 98% complete hematologic response within 4 weeks. Of
these patients, 31% had a major cytogenetic response and 13% had a
complete cytogenetic response. No maximum tolerated dose was
identified. Due to the fact that patients who took 400mg a day had
blood concentration levels of Gleevec that correlated well to the
optimal anti-leukemic activity in the lab, this dose was chosen as a
standard dose for Phase II trials.
- In 1999, 3 multinational Phase II trials were started where Gleevec
was given at a dose of 400mg a day to 532 late chronic phase
patients who had failed Interferon alpha. The other two trials
evaluated response to Gleevec in accelerated phase and blast crisis.
For results of 2nd line chronic phase patients, see the relevant page.
The long-term results of accelerated phase showed a 75% relapse
rate and a 93% relapse rate in blast crisis. Gleevec responses were
not durable for the majority in advanced phases of CML.
- Between 2000 and 2001, 1106 newly diagnosed patients with
chronic phase CML were recruited in the International Randomized
Study of Interferon versus STI571 (IRIS) trials and the 5 year results
of these trials are given on another page. These trials showed
Gleevec to have superiority over Interferon/Ara-C treatment making
Gleevec the first-line CML therapy.

