Saturday, May 20, 2017

5 Years Since I started on Ibrutinib for my CLL (chronic lymphocytic leukemia) in a Phase 1 Clinical Trial at Ohio State

May 5, 2017 marked 5 years since I swallowed my first 3 capsules of PCI-32765, now better known as ibrutinib or Imbruvica.
I still take 3 battleship grey capsules every morning to keep the CLL dragon at bay.
Much has changed in those five fateful years and I want to share some of my reflections on that amazing journey and some of my hard learned lessons.
I will be writing more about my story as a patient on these pages. You can get more of the past day by day blows over the last 9 plus years here in my blog  that in many ways was the mother to this website and the CLL Society. 
My very first blog post (, other than the portrait of me by my son, dates from April 29, 2008 and deals with another fateful decision, the one to have a transplant. Now with 1100 posts and 1.2 million views later, I am still telling my CLL story.
The Decision to Enter a Clinical Trial
In 2011, my CLL was not behaving. After my failed allogeneic hematopoietic stem cell (bone marrow) transplant, my nodes were growing again and became massive, over 11 cm long in the gut. My absolute lymphocyte count was also climbing, I had a mild anemia, but at least my platelets whose prior crashes from the auto-immune ITP (immune thrombocytopenia) had lead to five unpredictable and life-threatening hospital admissions were now holding steady on my immune suppressing cocktail of cyclosporine and rituximab.
I had added a small sub-clone of 17p deleted cells to my more dominant 11q deleted clone of bad actors. In fact I had developed several new mutations, more than enough to qualify as a complex karyotype. I had a very nasty flavor of CLL.
My CLL also had now clearly demonstrated genomic instability, the ability to continue to mutate and find ways around drugs meant to control it.
Chemo-immunotherapy (CIT) such as FCR (fludarabine, cyclophosphamide and rituximab) was off the table. It simply wouldn’t work due to my 17p deletion. My options were vanishingly few.
With a failed bone marrow transplant as part of my medical history, I was not only a high-risk patient, but also one excluded from most clinical trials. There is a lot of risk in clinical trials, and manufacturers want to eliminate as much as they can by excluding those who might disrupt the data such as post-transplant patients like me. This is still a common exclusion criterion.
Against this dark landscape, there was a tiny, but dazzlingly bright light. At the huge annual ASH (American Society of Hematology) meeting in San Diego December 10 – 13, 2011, there was a loud buzz about two new related therapies that were showing remarkable efficacy in very early and very small phase 1 trials in the worst of the worst CLL patients, such as yours truly.
And there was this remarkable moment of agreement between all the CLL experts, a moment never seen before or since, a consensus that we might be witnessing something special, that a new era might be dawning in CLL.
That feeling of a sea change coming turned out to be prescient.
Those two drugs were CAL 101 (now known as idelalisib or Zydelig) and PCI-32765 (now known as ibrutinib or Imbruvica).
Neither was available for me in California in a trial, but there was a trial opened in Columbus, Ohio at Ohio State University where I would likely qualify.
Clinical trial NCT01217749 (PCYC-1109-CA) would end up both changing and saving my life.
I had leveraged my position as a doctor and by this time, my modest fame as a CLL blogger, to wrangle an introduction to Dr. John Byrd in a noisy hall at the ASH conference. Within 10 minutes of talking, he had penciled me in for the clinical trial that he was running and so began our strong friendship.
I had to fight hard with my insurance company to get coverage for this out-of-state trial, but soon I had enrolled in the study and moved from sunny southern California to Columbus, Ohio for three wintery months.
I took my first three pills of PCI-32765 a little over five years ago.
In the next installment of this story, I will share more about the trial from the first days to the present, but for now I want to share a few “take- aways” from my adventure that I learned from this experience:
  • Don’t give up.
  • Think outside the box, or as Dr. Terry Hamblin would say: Think Laterally.
  • Leverage every advantage you have.
  • Be prepared to move, both physically and metaphorically, when you need to move.
  • Expect the unexpected- in this case, amazingly good results.
  • Remember to be grateful.
More to come…
Stay strong. Stay in touch.
We are all in this together.

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Blogger Unknown said...

Hi Brian, Thanks for sharing once again your amazing journey. You share more than just your story; you also share your knowledge, wisdom and strength. I am grateful to you personally for these gifts.

May 21, 2017 at 7:41 AM  
Anonymous Anonymous said...

Nice to see you reflecting again... will we see another magical moment in CLL in the coming years?

May 22, 2017 at 9:30 AM  
Blogger Unknown said...

I really liked the 5 year summary of your journey with Ibrutinib. This is my third attempt to comment - we'll see what happens. I wish to say you're leadership has made my own Ibrutinib journey (19months) so easy compared to what it would have been without you, your blog, your CLLSociety and the CLL Support Group.

May 22, 2017 at 7:24 PM  
Anonymous Anonymous said...

Your message of hope is comforting. Thank you taking time to share and offer encouragement to others. You always remind me that this is a group fight and that helps so much.

May 24, 2017 at 9:10 AM  
Anonymous Larry Hill said...

Dr. Koffman,
I appreciate your Blog as well as the CLL Society website in helping to give patients like myself some insight into making informed decisions about our treatment options. I've been following you as well as Dr. Furman and believe I've become a more CLL educated patient over the years since I was first diagnosed in 2010.
It was the issues with my enlarged lymph nodes that led my CLL Specialist, Dr. Ian Flinn, suggesting that it was now time for some form of treatment after 7 years of W&W.
I've chosen the Ibrutinib/Venetoclax combo trial as a way of hopefully obtaining MRD. I began one week ago and so far on Ibrutinib only I'm beginning to see my Lymph Nodes decrease considerably around my neck. Looking very hopeful for the future!
As you always say: "Stay Strong, We are all in this together"

May 30, 2017 at 8:51 AM  

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