On 1/23/2008
K. C. wrote:
Good Evening George;
What are the criteria for inclusion in this trial? (i.e. patient age, disease stage, response rate, etc.)
Also, how long did Phaze I take place?
Take care;
Kevin
Phase I extended over a two year period.
This investigation is being conducted at 20 locations with a total of 100 patients. There are about 20 pages of qualification stuff, but as I read them the patient has to be in relapse after at least two different treatments. From all the tests they are doing, it would appear that they are looking for patients with little or no physical damage and that have responded to prior teatments with CR. Also because the chemo need to be infused over a two day period each week (3 on then one rest) a patient needs to be close to the trial location.
Not sure who is the lead, but I think it maybe Mayo in Rochester. The sponsor is Proteclix.
Thats about all I know at this point, more later
George