I rarely cross post to Patient Power but today there is a story by a fellow CLL patient I have known for many years as DebinOz. She is one of the few I know of with a more aggressive form of CLL than mine. And I think she has more air miles than my 750,000 with United.
Len
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See: patientpower.info/10-years-...
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Transcript | 10 Years With CLL: Two Trials & Lifesaving CAR T-Cell Therapy
Andrew Schorr:
Hello, and welcome to Patient Power. Andrew Schorr here, in Southern California. Let's go to the next day, where we're joined by my friend, Deborah Sims, who's in Melbourne, Australia, and has been a CLL sister of mine for many years. Hi Deb, thanks for joining us.
Deborah Sims: Hi Andrew, thanks for having me. Good to see you.
Andrew Schorr:
Well, it's great to see you. And I purposely worn my multicolored happy shirt today, because I think this is an upbeat discussion we can have. And I think you probably, of anybody I know, you've gone down the windy road of chronic lymphocytic leukemia for so long. Let's see, starting in what year? 2011.
Deborah Sims: Yeah, I'm coming up to my 10 years now.
Andrew Schorr:
Oh my. And so that's been FCR, which I, and many other people had, who've had CLL for a while. But then you were told you needed a transplant, but there was no match. And then by good luck, you met our friend, John Gribben. And it meant being in a trial, but you were in Australia, the trial was in London. So, were camped out in London away from your three children for several months, seven months, right? And then commuting to London for checkups, right? All that. That's a lot of flying.
Deborah Sims: I was in Qantas’ top 0.03% of frequent flyers in 2016.
Andrew Schorr: Oh my goodness.
Deborah Sims: Up there with all the A-list celebrities.
Andrew Schorr:
But the trial worked for a while, didn't it? That was venetoclax (Venclexta) and obinutuzumab (Gazyva), and it worked for a while.
What Was Your Experience With Two Clinical Trials?
Deborah Sims:
I had one of the deepest responses they'd seen on drug. It was a Phase 1b. So, this is the expansion stage of a trial where they allow more patients to have it. But I was the first one to have obinutuzumab first, to lower the tumor burden and then rising venetoclax. So, I got to no detectable disease within seven months on that combination. And I have very aggressive CLL, and FCR hadn't managed to get me to no detectable disease. So, I was very, very grateful for that trial. And I stayed on trial for four years.
Andrew Schorr:
Well, we should be grateful for you because as you know, that combination was eventually approved. And so, lots of people gotten it and benefited and you did for a while, but it didn't stay that way. So you go back to Australia, you're on venetoclax continuing, but your CLL got the better of it. And then you were fortunate to eventually go on ibrutinib (Imbruvica).
To lead into what we're really going to talk about now. And that is an experimental approach for CLL, CAR T, chimeric antigen receptor T-cell therapy. And we're coming up on one year. It was not easy, and we're going to get into that in a second, but the point is, is there a sign of CLL in your body now?
Deborah Sims:
Nothing. And it's the first time I've been off all drugs, Andrew, in 10 years. I've got out all drugs and with a drug free remission. So, I've never had a drug free remission. So, I'm very grateful.
Andrew Schorr:
You have a lot to celebrate, the year anniversary coming up, but also your 48th birthday tomorrow.
Deborah Sims: Yes.
Andrew Schorr:
So, but you didn't know you were going to make it to this birthday?
Deborah Sims:
No. So, all my friends are busy putting Botox in their faces and worrying about getting old and I should have died five years ago. And that was my prognosis when I was diagnosed, was five years survival. And even when I relapsed on FCR six months after treatment, that five years actually became tighter, that became two years. So, it's amazing how far we've come, in a relatively short period of time.
And that's why part of our job now, because you are a beneficiary of clinical trials as well, is to tell patients, there is so much hope and it's about making sure that we empower ourselves the information to help our doctors find the best treatments for us at the best time. And that's why CAR T for me, I've probably gone much earlier into CAR T than I was comfortable with, because I was very well on ibrutinib. By six months on ibrutinib, my disease was under control, it was stable.
I was told I could have another two years on ibrutinib before resistance broke through, having eventually failed venetoclax. So, it was a massive decision to jump into CAR T at the time when I was well. But one thing I have learned over the years, is that you don't want CAR T as salvage therapy. You want CAR T, your best chance of it working is when you’re well. So, I made the decision, did it, all the way through COVID and here I am a year later, still no disease and on no drugs.
Andrew Schorr:
Wow. Well, it's a remarkable story. Now, of course, the question is CAR T is still a big gun. It's expensive. Some of the oral therapies that you've been on have been working for an extended time for some people. So, a lot of the research is who's it right for when? And we may look back and say, well, Deb was a pioneer. And that, as you say, maybe it'll be used earlier. We just don't know yet. So, one of the things that goes along with CAR-T is cytokine release syndrome, where you can be out of it or maybe have pain, but not a good situation. It's like going through quite a valley to get to the other side. You had that, right?
What Did the CAR T-Cell Therapy Process Entail?
Deborah Sims:
Yeah. And they didn't expect it. So, because I had so little disease going in, I mean, I barely qualified for the trial. I did it, but just, I had no palpable nodes, there was... My scans were clear. My blood work only... The bone marrow, there was a tiny bit of CLL showing. And so, I was only just MRD positive. Then I had three days of FCR and then they reinfused the CAR T-cells that had been re-engineered in America and flown back to Australia during COVID. So, I actually... It took eight weeks to get my cells back to me.
So it meant that I had to actually go through two lots of screening for the same trial. So, the second lot of bone marrow biopsies, I was pretty over. But when the CAR T-cells were infused, I was told to expect, maybe you'll feel a bit fluey, or maybe you won't feel great, but we're not expecting you to have cytokine release syndrome because you just don't have enough disease.
And on day 11, I emailed Con Tam and Michael Dickinson, who were my doctors at the Peter Mac and who's... It was Michael's trial. And I said, what happens if it's not working? Can you put more cells in? Shouldn't I be experiencing something? And literally an hour later, all of a sudden, I'm shivering. My skin is cold to touch. My bones start hurting. My bones start feeling as if someone is actually giving me a bone marrow biopsy everywhere. And I am in so much pain, that I was terrified. And we went to the Royal Melbourne hospital because part of the protocol during COVID was the Peter Mac could not take you without a COVID negative test. So, they gave me a test in the Royal Melbourne, put me in the high dependency unit. I was on 20-minute ops. And amazingly, every time they gave me Panadol (acetaminophen), the pain would dissipate.
So I was like, how good's Panadol? Panadol's the best drug I've ever had. Keep giving it to me. And I remember seeing Mary Ann Anderson the next morning, who's a wonderful CLL researcher, who's done a lot of work on venetoclax as well. I'd never met her in the flesh. And she was the doctor who came over from the Peter Mac and said, don't worry, we're getting you, we've got a wheelchair, we're getting you back out, getting you back over to ward 5A. And I said to her, "Mary Ann, when's the pain going to stop, what does the data say?" And she said, "You've been very brave. You are the data." And I was patient number... I think I was number five in the world. I think I had more CLL than they realized. And maybe that's why... Maybe I've got a little factory in my bones, in my legs or something, because that's where the pain really hid.
And then it lasted 36 hours and they really tried not to treat it. So, they were just giving me Panadol, fluids, let the T cells do their job. And then the worst of the pain ended. I can see why it's such an expensive thing to do, the level of care I got. I was under the care of 13 specialists. I was still under the care of a neurologist. It's a pretty intense thing to do. The admission at day 11 lasted longer than my initial admission for the T cells because they kept such close eye on me. So, all in all I was in the hospital I think for 16 days. But the worst of it was just this two-day period [inaudible 00:09:59].
Andrew Schorr:
Wow. So, Deb, let me ask you about this. So, you had the leading edge of immunotherapy, really. Coaxing your immune system, engineering it, to fight the CLL, which had been so difficult for your body over so many years to have a lasting response. Are you a believer? And you know a lot of doctors that, really harnessing the power of the immune system is where we're going to go with not just CLL care, but cancer care?
Deborah Sims:
Oh, absolutely. And you have spoken to Tanya Saddiqi, as I have, at the City of Hope. She strongly believes that CAR T for aggressive CLL patients should actually end up, hopefully will end up being second-line treatment. That we won't get to the stage where we fail, fail, fail, fail, fail, fail until you have no alternative, either to do a bone marrow transplant, stem cell transplant or CAR T. So, I think that is the future. What's wonderful with CAR T is it can be done with older people. It's not the harrowing... Even though that was a scary period for me, the recovery was instant. I bounced back. I was back at work, by a month after I was back at work.
And that's just being seen in the same in older people. Whereas we know there's a finite time for bone marrow transplant because the conditioning therapy and the recovery is just so slow. So that was my mental... That was my reasoning for having CAR T now, because it either works or it doesn't. So, it's very expensive if it doesn't work for you. And there's a paper out I read recently, which I'll give you the link for as well, which shows there is now a test to see how you might respond to CAR T. Which is really important, especially in America where you're having to spend so much money on this.
Andrew Schorr:
All right. So, let's talk about the future, 48th birthday tomorrow, year coming up CAR T, hopefully it just continues, no sign of CLL. How do you view the future when you've had so many highs, but lows along the way?
How Do You View the Future Now That There Is No Evidence of Disease?
Deborah Sims:
It's such a really, really good question, Andrew. I've been under the care of a psychologist since... Oh, about two years now. And that was when I started relapsing on venetoclax. I found that the mental strain and the mental fear was way in excess of any physical experience I was having. And to be honest, I've got friends who are going through CAR T and the thing I've said to them is, get a psychologist to help you through this, because actually my psychologist did telehealth. And I've been living as if I could die for 10 years.
I have... Every Christmas has been potentially my last Christmas, every birthday, making memories for my children, lots of exciting times, but always fearing that I'm not going to be there in two, three years’ time. And for the first time in this whole... I hate the word journey. But in the whole time that I've had cancer, I'm looking at... It may not be my cure, but I'm considering it to be my cure for as long as I can until I hear otherwise, because I can't keep living as if I'm going to die. My liver won't cope with it anyway.
Andrew Schorr:
Well, this is just a happy story, because I've spoken with you at various times along the way. You've been a pioneer in participating in clinical trials and have done it yet again. And let's hope that this is a lasting benefit and that you have many Christmases ahead of you, many birthdays ahead of you, and that the load that you've had psychologically can be released. Deborah Sims, thank you so much for joining us from Australia. And we wish you all the best.
Deborah Sims:
Thanks, Andrew. And I'm looking forward to more gray hair coming in, getting more wrinkles. I'm really, really relishing getting old. I appreciate that it's a gift denied to many, so very grateful to be here.
CAR-T trials
CAR T Therapy
