April 22, 2019 - Clinical Trial Updates and Plummeting Counts

Finally, a non backdated post. I am really going to try to make an effort to post everything here from now on because I spent the better part of all my free time these past 2 weeks trying to update this blog so that it tells my story all in one place. I think I will use the blog as a place to draft updates throughout the week and then publish and post on Facebook about every week to 10 days when I feel i have enough content. 

So far the trial is going ok. Every day I have to take 7 pills of the trial drug. I can't eat for 2 hrs before or 1 hr after so I normally wake up, take the pills, and go back to sleep for at least an hour so I can sleep through all the fasting. On clinic days (every wednesday) I have to take the pills at the clinic because certain labs need to be drawn first. So I try to eat a small breakfast when we first get on the road assuming it will be at least 2 hrs by the time we drive, get labs, see my Dr. Etc.

Last week we had a bit of a snafu with regards to the trial. When I agreed to start it we were given an informational packet with the consent forms at the back. The packet outlined specifics including when we would have to come to the clinic and what tests would be performed on those days. 

If you read the last update you know that on the first day we had a long day with blood draws and EKGs every so often up until 8 hours after taking the drug. Well in the packet I got it said the next long day like that would be on day 15. But we got over to the trial clinic for day 8 and they said it was another 8 hrs of testing that day. We were quite a bit upset because I also had to get a biopsy that day and needed platelets that i assumed I could get that day, saving us a trip for Thursday.  But with them needing to check my levels I wasnt allowed to get any blood products that day. 

After a little back and forth with the nurse about this she brought in the clinical trial administrator who gave us a copy of her protocol calendar. It did show that the long day was scheduled for day 8 and not 15, but it also had a ton of typos in it including spots where it referred to the previous study 3201a instead of my study 3201b. It was like they did a very poor copy and paste job and just seemed highly unprofessional that not only was my consent paperwork different from the actual schedule but that their schedule named another drug. 

In the end we decided to continue with the long day even though I hadnt originally consented to it and the nurse was able to get us $20 in vouchers for the cafe since we hadnt planned ahead for another 14hrs away from home day. 

As for side effects of the drug so far, I have very bad gas and increased neuropathy specifically on my left side. Back 3 summers ago when I first started chemo for my NET I used to get this weird warming sensation in my feet, where they feel hot internally but of you touch my foot from the outside it isn't hot. That is back. I also gained 7 lbs from day 1 to day 8 of the trial. And my good counts seem to be plummeting. 

On day 1 of the trial my hemoglobin was already low so I got blood on day 2. My platelets had been holding out around 30 for weeks before the trial and by day 8 they were at 16 and I had a lot of bruising and some bleeding so I had to get platelets on day 9. I get my blood checked on Mondays as a touch point between clinic appointments and today (Apr 22, trial day 13) my platelets were only 4!! And my hemoglobin, which had been 9.5 last Wednesday was down to 7.6. 

For reference on these counts a normal platelet level is at 150+ but they dont normally transfuse you until you drop to 10 or have symptoms like severe bruising and bleeding. Which is why I was able to get transfused last week at 16. On the hemoglobin normal level is 12+ and I transfuse at 8.0 or symptoms of dizziness and short of breath. The fact that they dropped back down so fast is scary to me. It means I may need to increase my frequency of blood draws so that I can make sure my levels stay good or I may even need to go back inpatient if my transfusion needs are too frequent. 

On top of my good counts tanking so terribly another concern is that blasts have started spilling into my blood. Blasts (aka leukemia cells) in my blood is how they initially suspected I might have AML and how they confirmed my initial relapse in October. Once I started the Decitibine + venetoclax in November my blood blasts eventually went to 0% and up until day 1 of the trial (Apr 10) had stayed there. They were only at 1% on that day but still concerning that now the level of blasts in my marrow was great enough that it was coming through on my blood work too. And on trial day 8 (Apr 17) that had increased to 2%. So I was concerned that I've been on the trial drug for a week and the percentage went up not down. But my doctor said we cant really judge or be concerned the trial isn't working until we get through the first month and take that cycle 2, day 1 biopsy (May 8) . The differential isnt back yet on my blood draw for today so I wont know until tomorrow if the blasts went back down, rose more, or stayed the same. 

So since I needed transfusion so desperately today we were able to coordinate with my local hematologist, Dr. Ashkar at Beaumont, and I am here now getting my blood and platelets. This saves us a trip to Ann Arbor and the possibility of having to also go back tomorrow for extra bags or go through the ER at UofM because over there the transfusion clinics close at like 6pm and here they have a special 4-bed outpatient transfusion room that is open late. 

So that is pretty much all the updates through (almost) the end of week 2 of the trial. More to come later.