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What You Should Know About CLL Clinical Trials

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Published on February 26, 2021

Should I Participate in a CLL Clinical Trial? 

How often do chronic lymphocytic leukemia (CLL) patients participate in clinical trials? What are the benefits? What does it take to be a candidate for a clinical trial? Finally, what do doctors wish all patients knew about clinical trials for CLL? 

In this video replay from our “Dinner with the Docs” event on living with CLL, Host and Patient Advocate Carol Preston guides an informative discussion with two Medical Oncologists/Hematologists at Rocky Mountain Cancer Centers, Dr. Austin Poole, MD, and Dr. David Andorsky, MD. They both practice at the center’s Boulder location and are highly regarded experts in the field. Stay tuned to learn more.

Support for this series has been provided by Janssen Oncology and Pharmacyclics LLC. Patient Power maintains complete editorial control and is solely responsible for program content.

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Transcript | What You Should Know About CLL Clinical Trials

Carol Preston: Good evening, Colorado, and welcome to Dinner with the Docs with our chronic lymphocytic leukemia (CLL) medical experts from the Rocky Mountain Cancer Centers. I have been living with CLL for 14 and a half years. Here with us this evening are Dr. Austin Poole and Dr. David Andorsky from RMCC. Dr. Poole, would you please introduce yourself?

Dr. Poole: Sure. Hey. Hey, everyone. Thanks for having me. My name is Austin Poole. I work here at Rocky Mountain Cancer in Boulder. I have the privilege of having joined here a few years ago thanks to the graciousness of Dr. Andorsky and the rest of my group here.

Carol Preston: Very good. Dr. Andorsky, would you introduce yourself?

Dr. Andorsky: Sure. My name is David Andorsky. I'm a medical oncologist/hematologist working at the Rocky Mountain Cancer Center in Boulder. I've been with the group for about 10 years. I'm also one of the Associate Chairs of the US Oncology Research Committee, so I'm very involved in hematology research, we run clinical trials at our practice. It's a very exciting time for a lot of different cancers in terms of the progress we've been making, but especially for CLL.

Carol Preston: We have another poll and we want to sort of move into the clinical trial area. It is simply this: have you participated in a clinical trial? Yes or no. Hopefully, we're finding an increasing number of people who are willing, if they can find clinical trials, to do so. In the past, a lot of people shied away from them because A) they felt they were guinea pigs or B) they thought maybe they were going to get a placebo, which is not the gold standard of trials for cancer. About three quarters of our audience tonight says, no, they've not participated in the clinical trial, but a quarter have, which is a pretty good number. The Patient Power audience may be more up on that than others. But what do you think about those numbers, that a quarter of our audience tonight has participated in clinical trials? Dr. Andorsky?

How Many Patients Participate in CLL Clinical Trials? What Are the Benefits?

Dr. Andorsky: It's definitely much higher than average. When the National Cancer Institute tries to benchmark centers to say, "Well, are you putting enough patients on clinical trials?" Usually, the cutoff is 4% for a community organization and 8% for an academic institution. So, 24% is a very high number. I'm a very big booster of clinical trials for several reasons. One is, that's how all these new drugs were developed, is they had to be tested and shown to be better. So certainly, there's an altruistic aspect to it.

I also tell patients that it's a good chance often to get in early to a drug that may be very promising, especially a drug that's later on in its development where we have a lot of safety data where we think it does look really effective. That could also be a good opportunity for the patient as well, to get something newer before it gets out onto the market. It's enabled me to get experience using these new medications in the context of the trial before they're then FDA approved. Then when venetoclax (Venclexta) gets approved, I already know how to use it because I put patients on studies. So, it's also, I think, good for the clinicians as well to participate in trials as well and try to deepen their own knowledge in that way.

Carol Preston: Dr. Poole, what kind of pushback do you get? Have you also encouraged patients to participate in clinical trials?

Dr. Poole: Yeah, I think I'm with David. I think we try to get patients to participate as much as possible in clinical trials. I think, again, I think it also comes down to the heterogeneity of CLL. I think I'm more likely to encourage someone with a 17p deletion, sort of like yourself, to participate in a clinical trial knowing there's maybe not quite as many good options and you may not get as much out of them as someone who has a lower risk disease. So, I think that's part of it too. Our job as oncologists isn't just to say, "When we say turn left, turn left." Our job is to say, "What matters to you? What's important to you?" and try to then sort of bend the medical system towards your goals.

I think for some people, it's like, "I don't want to be part of a clinical trial because I don't want to come to the clinic every four weeks. I'd love to have a new trial - I'd love to be on something new but get me out of here." So, I think just trying to kind of get even down to that level in terms of an individualized sort of situation. But yeah, I think we always try to encourage people for clinical trials and we're doing a lot of clinical trials that aren't just sort of "experimental" clinical trials. They are not FDA approved, but oftentimes they have good safety data; they've been used before in humans and things like that.

Carol Preston: So a follow-up to that would be if I've been in a clinical trial or if one has, once you've been in treatment, does that mean that you no longer are a candidate for any future clinical trials?

What Makes Someone a Candidate for a Clinical Trial?

Dr. Andorsky: In fact, the opposite. Most clinical trials are designed to look at patients at a certain phase in their illness. So typically, the earlier trials with a new medication will involve patients that have already received the standard therapies and now, they're kind of running out of options. That's because, again, when we're testing a drug, especially early on, we don't know if it's going to work or not. So, if you have a tried-and-true treatment that we know is effective, we want you to try it first. As things go along, then the drug gets earlier and earlier in development. So venetoclax is a great example. That started with relapsed and refractory patients. Probably most patients in the early studies had had four or five therapies, and then it certainly got walked back. Rocky Mountain Cancer Center participated in a clinical trial that ended about a year or two ago that we looked at venetoclax in the first line. So, certainly being in one clinical trial doesn't preclude you from being in another one. It's all about what is the study population that that trial is trying to study, and do you fit those criteria?

So, if you had a patient that had acalabrutinib (Calquence) and their disease progressed, they wouldn't be a good candidate for another trial with acalabrutinib, because you know that's not going to work in that individual. So sometimes it's just not the right fit based on the drug combinations that are being used. But whenever I see a patient and I'm thinking this patient needs to be treated, I always think, okay, what are my standard of care options? And then what are the clinical trial options that we have here, or that I know we've got with our partner institutions down in Denver? And then talk to the patient on what's the best fit for them at that point.

Carol Preston: Can one of you talk a little bit about the LOXO trial for refractory patients? What is it, and how this trial is moving forward?

What Is the LOXO-305 Trial for CLL Patients?

Dr. Andorsky: So, the LOXO compound is a new sort of next generation BTK inhibitor. It seems to work in patients that have progressed on things like ibrutinib (Imbruvica) or acalabrutinib. So, it's a very promising medication. It seems to target a different part of the BTK molecule. Beyond that, we don't have any of the LOXO trials open for CLL at RMCC. I'm not directly involved with them, so I can't really comment on data or how it's going. It's really a very promising avenue. This is a very common theme in oncology. Ibrutinib was a real breakthrough. Suddenly, you had a pill that could treat CLL, and now people say, "Well, how can we improve on ibrutinib?" That's how you got acalabrutinib. Zanubrutinib (Brukinsa) is from a Chinese company that also seems to be very effective. "What happens if patients progress on those? Can you tweak the molecule so that it keeps working in those patients without resistance?" So, yeah, it's really a very promising area of research.

Carol Preston: Clearly you do have hope for the future of CLL, given what's been going on from the last several years. I think patients hope there'll be a cure. What do you hope for?

What Are Your Hopes for CLL Treatment in the Future?

Dr. Andorsky: I hope there would be a cure too, but I hope that if we can't get to a cure, we can at least get to the point where this is a disease that people can live with and they can live full active lives with minimal side effects from treatment. And again, I think that's becoming more and more possible with these newer therapies.

Carol Preston: And Dr. Poole, ending on an optimistic note, clearly you are someone who has hope. You do have hope. And what are you hoping for in the future?

Dr. Poole: Yeah, I think it would be great to have a cure by the way, for all of this stuff. It would be amazing. If I didn't have a job tomorrow, it would be amazing. But I think, to David's point, I think, I'm not that old and in the beginning of my fellowship, which wasn't that long ago, we were still sending patients for transplant to talk about allogeneic stem cell transplants for CLL. I'm not sure I'm going to do that ever again. I'm not sure that that's where we're headed. And so even within my short career, I've had to just be like, "Oh, this has changed. This has changed. This has changed." And so, I think there is a lot of optimism and enthusiasm, and I think it's great. I am hopeful.

Carol Preston: Well, as are we. And we're so fortunate to have physicians like Dr. David Andorsky and Dr. Austin Poole in our corner, we who have CLL. For Patient Power and our partners at the Rocky Mountain Cancer Centers, in particular Dr. Andorsky, Dr. Poole, I'm Carol Preston, reminding you to please keep asking questions. They do lead to more informed treatment decisions for improved outcomes. 

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