ImetelChat

Lacour, the IMAGINE study doesn't appear to have a primary end point at 54 months as you initially thought. It looks more like the 36 patients will be accrued over a 54 month period but the study is scheduled to end after 114 months. So in round numbers 36 patient are treated over a period of a little less than 5 years in a phase one dose safety study and some (or at least one) is/are expected to last until a little less than 10 years. (What??) The life expectancy currently, as it stands now in relapsed refractory AML is measured in months, not years. Something strange here. I can't quite make sense of this. So far only one institution (apparently investigator sponsored) listed. Maybe more coming but It seems a little bit of a stretch on several levels. A phase one safety study lasting 5 years for enrollment, with a timeline of 10 years to complete the study? Surely many other treatments will evolve by then. I truly can't make sense of this protocol timeline. Take a look at the long list of articles referred to in the clinical trials site. There is even a nod to Dr. Hayflick's article from the '60s.

i had the same questions - something didn't make sense - only 36 participants for a disease that should give you an answer quickly if it is working or not - would expect it to take a year or two tops

I spent some time on Copilot digging into this. Unfortunately, for a phase 1 trial for a niche disease, this seems to be normal.
Very restrictive criteria to get onto the trial, with limited funding to support it. Large time scale to allow them to wait for the exact people to filter through.
Phase 2 would be the ramp-up into the hundreds.
It does seem to be utter insanity that this is the way drug trial progression still works.

A real head scratcher on a number of fronts. Hopefully more to come. While Geron is now under a new management team, previous management hyped this trial and the previous single agent CT to get to IMagine, now crickets.