At a visit to the Hammersmith last week, Val was told of a new trial being considered by the Hammersmith. They are not going to follow STIM (ie stopping Glivec all at once and close monitoring as in France). It is likely they will first go to a half-dose (ie 200mg) with close monitoring) for volunteers who have low and long term stable PCR results. I am not sure when this trial will start but probably in 2012. It will be like STIM but varied by going first to a smaller dose.
David
Hi David,
I was told the same at Liverpool in September. Prof Clark said, the dose would be lowered to 200mg for 12 months, and if all is still good with PCR results then we may be able to come off it altogether. I will be more than willing to take part. Exciting. He too said 2012, he said by the time they get the go ahead. He has a mental date of about june / july. I'm hoping it's sooner.
Liz. x
A trial to come off Glivec is exciting. Close monitoring of patients taking reduced dose 200mg will detect any relapse early. From reading earlier posts I understand that the relapsers would go straight back onto Glivec 400mg with every chance of regaining their PRCU. What is the risk of the time spent on the 200mg of causing a Glivec resistance so reducing their chances of regaining PRCU?
Hi all
I had heard something similar from the Hammersmith in the Summer although not the details, so those are interesting. On the question of risk, I wonder if anyone can answer that question with any certainty but for those who may be offered the trial (and I think they will do that with me) it is one to ask. I will also be asking about how the monitoring is carried out, what they know about me now (ie on more sensitive PCRs where am I?), etc, before I decide. It would be good to come off but naturally I do have some concerns about the risk, even though the French trial suggests patients who did experience recurrance regained their responses.
Richard
Hi
Although very willing, I will also be asking lots of questions. Last year I asked my Cml nurse if I could drop my Glivec to 200mg, her response was that it wasn't a therapeutic dose, and not possible. Not quite sure what has changed. I only thought of it once I left clinic. Will be checking up on that.
Liz x
I'm under Professor Clark in Liverpool, but now only see him once a year. Dr Heartin at Glan Clwyd mentioned the STIM trial last month, and my first reaction was one of reluctance, especially as I'm still on 600mg of Imatinib and neither consultant has wanted to reduce this in the 6 years I've been on the drug.
So the trial to reduce to 200mg - is this just a way of reducing costs (a sop to NICE???) or to mitigate side effects? As my side effects are minimal (fatigue, night sweats and photosensitivity) I really don't know whether I would volunteer for either trial.
Terry
North Wales
To be perfectly honest, I find this trial dangerous.
Sub optimal doses can result in resistance!
Will they be monitoring Glivec concentration in the blood at the same time to see whether the patients are getting enough of the drug to control their disease?
I think the assumption must be that the understandings about what is necessary to achieve optimal response don't apply to long term maintenance of that response in at least a subset of patients. That would mean there is a difference between sub optimal doses without long term CMR and with long term CMR - though exactly what it is I don't know, and I don't think anyone does (and there's CMR, and there's CMR....). I think it must therefore be being assumed that the amount needed to control disease, and/or avoid resistance, at this level of response is below or well below the standard therapeutic amount. As I understand it, the trial would only be open to patients with documented CMR for at least 24 months, as in the French trial. I guess the idea is that group of patients has such a very low (and stable) level of disease, a lower dose may be OK. The French trial seems to suggest that for some, no dose may be OK, and the UK trial is going to see if a gradual step down means more can stop without recurrance. Patients with some level of detectable disease, MMR or above, won't be on the trial or lower doses for the reasons you give.
I suppose this is all delving into the unknown and there must be some risks - so I will be discussing in detail if offered. I have been told I am an "ideal" candidate for such a trial - but I do have doubts about going on it, absolutely.
