I respond several times a week to other posts, but having written one. I am participating at the OSU trial and since I've benefited from hearing about other people's trial experience, I thought it might help to share mine.
I first was diagnosed in December via lymph node biopsy and am 48 and am 17p deleted, unmutated IgHV, have complex karyotypes and was untreated before today. My counts are not super bad, but I have very bulky lymph nodes everywhere. The most spectacular one is in my stomach and is 11.3 x 5.2 cm as of last Tuesday!
Anyhow, I started at a regional hospital, went to Penn for a second opinion and they were going to start my on ibrutinib in March. Though the doc at Penn was really well regarded, my friends weren't satisfied and pushed me to try to get to MD Anderson or Dana Farber. Long story short, I ended up getting into see Dr. John Byrd at OSU and I knew immediately he was the doctor for me. And when he actually remembered who I was the second time I saw him, I was floored. There is a lot of talk about how much of a CLL genius he is, but he is equally kind and humble-a rare combination. He takes his time to get to know you, and really digs deeply into your medical history.
The guy at Penn thought I was insane for considering the clinical trial, because overall response and survival rates have been good, even with 17p deleted patients. But what we have seen in the past few month are studies coming out that we tend to relapse more quickly and are also more likely to be hit Richter's Transformation. By the way, they have identified a mutation that shows if you are more likely to progress to an RT. I got tested and I don’t have that mutation so I’m only 10% likely, rather than 40% likely.
But I digress. Back to the trial. It’s basically a cocktail of three drugs and the thinking is that if they hit the disease in three different ways, it might cure some people and put others into more durable remissions. Further, unlike some of the other novel agents, you take the drugs for 14 months and then you stop. Phase 1 you start with obinutuzumab, and in phase 2 and 3 they add ibrutibnib and venetoclax respectively. The consent form was 25 pages long, and the majority of the pages explained the risks.
Day 1 and 2 are an obinutuzumab infusion days. They ease your body in by giving you 100 mg the first day, and 900 mg the second day. They also say the first day is the worst, because your body isn’t surprised by the drug the second day.
I got to OSU at 7:15 for registration and then at 7:30 had labs pulled. They have to wait for them to come back because if your numbers are too low (e.g. hemoglobin < 8), you are ineligible.
My counts were:
White Blood Count 92 (normal high 11 - because so many are hiding in the lymph nodes)
Red Blood Count 3.39 (normal low 3.8)
Hemoglobin 9.7 (normal low 11.7)
Platelets 179 (normal low 150)
Once you are cleared, pharmacy mixes up the drugs. Meanwhile, they put you on fluids so you are in better shape to get rid of all of the stuff your blood is flooded with when the cancer cells are destroyed.
Then they get you on the IV drip. This happened at 11 am, and it took a little over 4 hours. The list of potential side effects is quite similar to normal chemo, but they gave me 5 drugs to try to mitigate them. In my case, I only felt icky for about an hour, and after two hours (because I was knocked out by the Benadryl they gave me), I was checking work email. I had chills (but didn’t get to shivering which would have been a problem) and I felt not quite what I would describe as nauseous but more of a general stomach malaise. They take your vitals every 15 minutes for the first couple of hours and then back off to every 30 minutes.
If you have major side effects, they stop the drip and wait for them to pass. Sometimes you don’t even get thought the whole bag. This wasn’t the case for me, but I thought it was worth mentioning.
After you’re off the drip, you need to stay two extra hours so they can observe you. I got dismissed at 5:20 pm. It was long day, but I felt well enough to walk the .7 miles to my hotel room rather than take an Uber.
Tomorrow I get to repeat the whole thing. Obinutubumab is fast acting, so it will be interested to see what my numbers look like tomorrow.