6 replies to this topic

[JoshLee]

Hi,

      So I am going to the University of Michigan this week because I can't seem to get my PCR under 1% international scale and I just hit the 18 month mark. Dr. Talpaz is thinking of having me enroll in a trial. I believe it is this one: https://www.umms.med...&id=5952&TYPE=

Is anyone else in this trial or has any one heard how it is going? Thanks for the input. -Josh

[Trey]

SMO Hedgehog inhibitors have shown some promise in CML, but have mainly been tested on solid tumors.  The clinical trial for CML using Sprycel + SMO Hedgehog inhibitor has been ongoing for 2 years and has not yet enrolled the 36 patients they had hoped to get, so it has apparently gone a bit slow, and there is no preliminary report out.  I have not heard anyone discuss being in the trial.  I'm sure they would like to get some more participants, so this is a chance to be part of this if you wish.  Clinical trials are a chance to push the edges of the envelope in drug development and potentially make a difference.  Phase I trials generally have the highest risk of clinical trials, so get all the info first, but there have been quite a few trials using the drug on solid tumors, so the safety profile should be reasonably established.  The combo trial has been suggested as a potential "cure" for CML, so at least some of us would like to see you in the trial.  So it would be interesting to watch you do this, but "interesting" to an observer is not the same as "participating".  Overall it sounds like a reasonable plan, and Dr Talpaz would watch you carefully. 

http://clinicaltrial...term=BMS-833923

http://community.lls.org/thread/12674

[chriskuo]

Which drugs have you taken so far?

[Elizablest]

I would love to be on this trial. I have had an interest in the development in SMO Hedgehog inhibitors before I was dx w CML. But, is seems very difficult to fill the slot for 36 patients when they are asking for those who have failed TKI treatment. Seems to me that is too late to get anyone to have the chance sign up. Seems it would be too late to suddenly expect the trial to be successful. Seems it's setting up the trial to fail even before it's begun. Is there any evidence that it would work on someone whose body is already failing?

[JoshLee]

Hi,

@Chriskuo, I have been on Tasigna 300 mg x2 daily and 400 mg x2 daily for about 18 months. I had a pretty raid response on my FISH in the first 3 months. I dropped from 98% to 22% and then I slowed down. The next two months I dropped down to 10% and then I had stalled about around 1.3% IS for the past year. I was confirmed CCyR on two BMB's about 3 months a part. PCR has bobbled up and down, but I have never crossed the threshold. I am young so I want to push for MMR because I want to hold the response longer. I've been patient and it's time to pull the trigger and take action, so I am going to see Dr. Talpaz. I haven't tried Sprycel yet so that is an option, but I got an email from Talpaz and he told me there's another study going for ponatinib that he's interested in trying to get me into. Who knows what will happen? Just trying to keep the faith. 

[Cliffee]

I'm surprised he hasn't had you try Sprycel? Ive read several posts from people in this forum that had no luck with Gleevac then Tasigna, and Sprycell worked wonders.

I would be pushing to give Sprycell a chance since it works diffentely than Tasigna.

Have you had a mutation test?

[chriskuo]

Will this be your 1st visit to Dr Talpaz?

I thought the new ponatinib trial was for newly diagnosed patients.