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What CLL Patients Need to Know About Clinical Trials

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Published on May 7, 2020

Key Takeaways

“I think if you can get into a well-designed clinical trial, even as your first therapy, then I absolutely would encourage that,” says Dr. Ian Flinn, dispelling the notion that clinical trials are a last resort for chronic lymphocytic leukemia (CLL) patients.

In this segment from a recent town meeting, Dr. Flinn, a CLL expert from Tennessee Oncology, discusses clinical trials and explains why patients should consider joining one early in treatment. He also shares the latest trial updates and what new therapies are on the horizon. Tune in to learn more.

This program is sponsored by AbbVie, Inc., Genentech, Inc. and Adaptive Biotechnologies. These organizations have no editorial control. It is produced by Patient Power in partnership with Tennessee Oncology, Bag It, and CLL Society. Patient Power is solely responsible for program content.       

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Transcript | What CLL Patients Need to Know About Clinical Trials

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Esther Schorr:

Hi there, this is Esther Schorr. Recently, Andrew and I co-hosted a virtual town meeting and learned from leading CLL experts about treatments, clinical trials and lots more. Let's listen in as we navigate through a CLL diagnosis.

Andrew Schorr:

Esther, let's talk about clinical trials for a minute. So I was in two, and you saw I had to sign a bunch of papers, and they had black boxes and this in bold face and stuff. It was a little daunting, wasn't it? 

Esther Schorr:

It was daunting, but looking in retrospect, I think you would agree, Andrew, that the experience with the FCR trial, you ended up with a 17-year remission, and there's something to be said for looking at the risk/benefits, correct?

Andrew Schorr:

Right, right. So Ian, do you want to talk about clinical trials? You're a researcher. So where are we with clinical trials, and what do you want to say to patients, your patients or people around the world in considering a clinical trial.

Dr. Flinn:

Yeah, I mean I want to build on Esther's point there about how daunting looking at this paperwork is. I mean, when I started my career, by regulation the written consent form had to be three pages or less, and had to be at the 8th grade reading level or less. Now people come in, and it's gone the opposite way. It's gone to 15 pages and you feel like you need your lawyer there to understand it. I would just say, "Listen, don't lose the forest for the trees," right? I mean, you really need to see the big picture, and that's what I do when I sit and talk to patients, I try to have them understand the big picture, the questions that are not all the nitty-gritty about every time you need to draw blood or all those side effects.

But the other thing I would say is that oftentimes being part of clinical trials, you will get the access to these therapies long before they become commercially available. So for instance, we had some of the first patients on ibrutinib (Imbruvica). Well, they received ibrutinib five years or six years before it was commercially available. The other guests, they've been part of clinical trials, they received these therapies long before they were available. 

And so I think there's this notion that, "I only want to be in a clinical trial if something's not going well." I argue the opposite. I mean, I think if you can get into a well-designed and a good clinical trial even as your first therapy, then I absolutely would encourage that.

Esther Schorr:

There is something else that I noticed when Andrew was going through his clinical trial was that the level of care is so intense that you're being monitored all the time. You're actively involved in dialogue about what's happening to you. I know as a care partner I was given the opportunity to ask a gazillion questions. So I feel like the fringe benefit of a clinical trial is also that everybody is very focused on exactly what's going on for you as a patient in the trial. Not that you wouldn't give great treatment otherwise, but it's such a controlled environment that there's very big focus on outcomes with the patients, so you're getting a lot of TLC in that process.

Dr. Flinn:

I think that's absolutely true. There's another layer, the research nurse is there to hold your hand, navigate all these different things. But just to build on that, we know from the history of oncology that even if you're in a randomized trial where half the patients are getting the standard therapy and other half are getting the experimental therapy, the patients on the standard arm do better than if you were not in the clinical trial. And there are lot of theories of why that might be, but one of them is what you've just pointed out, that you have a research nurse there, you have an extra level of care.  

And it's the collective wisdom about when to treat and when not to treat, how do adjust medicines, and so forth. So I think being part of a clinical trial really should be everyone's first choice if it's a good clinical trial. 

Andrew Schorr:

So you're combining drugs now, and there are other drugs in these classes, certainly the BTK inhibitors, that are in trials. So what's going on there? Is it all about combinations, is that where we're going, Ian? 

Dr. Flinn:

I think that in the frontline setting, I mean, the goal was to get people into very, very deep remissions, to have very, very long remissions, and put off second-line treatments. So in the frontline, it definitely is all about combinations. I mean, we live our own experience. I think oncologists first learned from the infectious disease doctors in fighting TB and other diseases, about to use combination therapies that are more effective in most cancers we treat.

And then we learned that, and it goes back and forth. But just like in chemoimmunotherapy, the combinations are going to be more effective than single agents. And the reason that we're able probably to get people off some of these treatments, these time-limited therapies, is because the remissions are very deep. With the BTK inhibitors, whether it's ibrutinib or acalabrutinib (Calquence), we know that the goals aren't only actually to get people into a complete remission, they are to manage the therapy as long as possible.

Andrew Schorr:

Okay, but where you're going particularly with the use of venetoclax (Venclexta) or with obinutuzumab (Gazyva) is to try to get people to what you called a time-limited thing, where you don't take anything, right? 

Dr. Flinn:

Exactly. And I think Nathan will talk about it, he's in a clinical trial where these very questions are being asked about if we get someone, whether—almost all these therapies that are getting people into MRD-negative include venetoclax. But they often include a BTK inhibitor, and they might include all three with Gazyva. But the big questions are, "If you get someone to be MRD-negative, then should we continue with other therapies at that time? Should we keep someone on a BTK inhibitor, or should we take them off? And then if you're not MRD-negative, should we keep people on that? Or what therapy should they stay on? Should I use more than one drug?" And so a lot of questions to be answered. People have their ideas about what's better, but no one really knows.

Andrew Schorr:

And if you stopped, if somebody gets a vacation, if you will, maybe for an extended time where they got to MRD-negative and they say, "I don't want to take any pills," or, "I just want to stop. Yay, I'm MRD-negative." If there are indications for treatment down the road, was there a penalty for stopping? 

Dr. Flinn:

So, I mean, I think if someone was MRD-negative and they came off, then I don't know that there's a penalty, right? It might actually be better. Say someone took venetoclax and Gazyva for a year, and they had a remission that lasts five or six years, well you could imagine just going back to that same therapy again. So I don't know that there's a penalty to be paid by stopping therapies, but we do have trials going on that will answer those questions. The good news and the bad news is that this is going to take a really long time to figure out, that's the bad news. The good news is the reason it's going to take forever is that people are doing so well, right? And so it's a good problem to have.  

Esther Schorr:

I know in the context of what's going on with the virus, with the pandemic here, in some areas clinical trials have been impacted. Can you comment, is something changing in terms of the CLL clinical trial landscape right now, as far as people being able to be in the trial, or trials stopping because of everything else going on?

Dr. Flinn:

I mean, I think it depends on the individual trial and sponsor. For the most part, at least at our center, our trials have gone on uninterrupted. Now, some of the sponsors of the trials are giving out guidance and saying, "Listen, maybe you're better off shipping the drug to the patient for the next couple of months, rather than having them come in and picking up the things." And so they're having allowances, they're making it more flexible for patients necessarily to adapt in this very immediate period with COVID-19.   

Andrew Schorr:

Right. Let me just make a couple of comments. So, Dr. Flinn, folks, is a specialist in this, and he's devoted his life to it. Not every hematologist has that specialization, so we would always say A, have a consultation at least with someone who is a CLL specialist even if your more general hematologist is involved in your care, that's fine, right? There can be partnership. And then also always ask about trials, okay? Always ask about trials. Might you get tomorrow's medicine today. Obviously, we're blessed with so many new choices now in CLL, and even for people who had those prognostic factors that we were talking about earlier, 17p, unmutated, et cetera, and now we have medicines that are helping handle that better than ever before. 

All that came out of trials. So if someone like Dr. Flinn is your doctor, or I have Dr. Kipps in San Diego, these CLL super specialists, have that conversation. And if you have a doctor who's more general, say, "Is there a trial that could be right for me, either that you do or that's down the road maybe at the academic medical center, at Tennessee Oncology, wherever?" And you have that discussion. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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