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CLL Clinical Trials and Treatment During COVID-19

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Published on June 10, 2020

Chronic lymphocytic leukemia (CLL) patients want to know if treatment can continue as normal despite the coronavirus pandemic. Are oral therapies safer than infused therapies right now? What about clinical trials that require hospital visits?

In this segment from our recent Answers Now program, host Andrew Schorr talks to two leading experts, Dr. Philip Thompson from the University of Texas MD Anderson Cancer Center and Dr. John Allan from Weill Cornell, and CLL patient advocate Jeff Folloder. Tune in as they cover important topics like treatment goals, risks and benefits of clinical trials, and what factors need to be considered during the coronavirus pandemic.

If you missed Part 1 and Part 2 of this series, watch them at CLL Patient Concerns in the Middle of Coronavirus and Is CLL Care Finally Returning to Normal?

This program is sponsored by AbbVie, Inc. and Genentech, Inc.  These organizations have no editorial control. It is produced by Patient Power.  Patient Power is solely responsible for program content.

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Transcript | CLL Clinical Trials and Treatment During COVID-19

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.

Recorded on June 4, 2020

Andrew Schorr:

Welcome to the CLL Answers Now program. I'm Andrew Schorr in Southern California. Joining us is a great panel today. Thank you so much for being with us. There's Dr. Phil Thompson at MD Anderson in Houston, Texas; Dr. John Allan, who is at Weill Cornell in New York Presbyterian in New York City; and Jeff Folloder, a CLL patient like me. Jeff joins us from Houston, Texas.

So, Dr. Phil Thompson. First of all, Jeff had a lot of credit to MD Anderson as a Houston patient and the safety there. So, what is your feeling about being able to offer the full range of treatment now? And what is your view about, at this point, whether people should delay for some reason, whether initial treatment or retreatment?

How do Different Treatments Affect COVID-19?

Dr. Thompson:

I think I would say that the coronavirus is one aspect of making that decision. I think, through a combination of good fortune and good management at Anderson, we've had very, very few patients that have got COVID-19. Likewise, very few staff members that have got COVID-19. So, we have an extremely aggressive screening program, and so we're very proactive about separating people from each other; everyone wears a mask in a building, which makes an enormous difference in terms of transmission. I think we can do the full range of treatments safely. We don't yet know to what degree different treatments impact your risk of severe COVID-19. So a lot of that decision about what treatment to use when is based on theories rather than data.  

But if I have a patient where the indication for treatment is a bit borderline, then I think it's reasonable in the current environment to delay. However, if I had someone who had a hemoglobin of 7 and enormous lymph nodes, I wouldn't delay treatment in that patient. So, I think it's a very patient-specific decision.

As far as the type of treatment to use, I think there may be advantages to using a treatment that doesn't require the patient to come in a lot of times to the hospital. With the caveat that, as I said, I think it's actually a very safe environment. I think people are far more likely to get COVID-19 from going out to a local restaurant than they are coming to a place like MD Anderson, which is a cancer-specific hospital. It's not a 911 center where patients with COVID are being brought there. Cancer patients are very proactive about their health and about social distancing. So, the likelihood you're going to actually get COVID-19 from coming to the hospital, I think is very, very low compared to a general community setting.

Andrew Schorr:

Okay. So Dr. Allan mentioned about clinical trials getting going again at Weill Cornell in New York, your big research center too. So you're doing research, for instance, in CLL, on not just CARs, chimeric antigen receptors with T cells, but with natural killer cells, CAR-NK, very leading edge. And we all will watch that to say, "Well, does this apply to us?"         

So, can you both with the full range of approved therapies, some of which require infusions or more testing, or even with research, do you feel confident that can move forward now, so that whether it's Jeff, or me, or any of our viewers, you can make a recommendation from the full range of what you have, and we can move forward with confidence?

Is it Safe to Enroll in a Clinical Trial During COVID-19?

Dr. Thompson:

I would say yes. So, most of our important clinical trials are open. Our frontline clinical trials in CLL are open and enrolling patients. I think that still, when you have cancer, if you need treatment, the most important thing is to treat the cancer the best that you can rather than worrying about theoretical risk of contracting the virus. So, yeah, we still have our full range of clinical trials.         

And you mentioned CAR T and CAR-NK, we're not using those treatments in patients who would otherwise be watch and wait. Those are treatments generally for people who have been through a lot of treatments before, maybe don't have a lot of standard options. And usually those patients can't afford to wait a long time, or they'll become very sick from their disease. So actually, it's important that those are still available, because in those patients they're more likely to die from untreated CLL than they are from COVID.

Andrew Schorr:

Okay. And so, again, with the approved therapies, and so Dr. Allan was talking about CD20 therapies - I received FCR years ago, and many people have over a number of years, the “R” being rituximab, a CD20 targeted therapy, which has to be infused to some degree, even though there are new delivery systems; or obinutuzumab (Gazyva), an infused therapy, or others that you've had. So that still remains part of the reasonable treatment, right? In other words, these infused therapies, along with oral therapies, what combination might work for you, and you make a judgment of that with your patients now. Okay. That's a yes, right?

Dr. Thompson:

Yes. So, as I was saying before, I think when, when you've got one treatment which is clearly the best option for a patient, you should do that. If you have several options where you're not really a hundred percent clear what the best choice would be, and you could make an argument either way, then things like how often does the patient have to come to the hospital may weigh into that.   

So, for example, if you were deciding between venetoclax and obinutuzumab, for example, versus say ibrutinib (Imbruvica) or acalabrutinib (Calquence), certainly the BTK inhibitor, the acalabrutinib or ibrutinib, you wouldn't have to come to the hospital as often. And so, some patients who maybe have to travel a long way, or are worried about coming in very often for blood tests and infusions, they may prefer to have that as the treatment, rather than a treatment that requires more intensive patient contact with the hospital system.

Andrew Schorr:

Right. But the other question I'd bring up—so I had FCR and Jeff, did you originally have FCR?

Jeff Folloder:

I had ofatumumab (Arzerra).

Andrew Schorr:

Right. That's right. But we had different infused therapies, but the idea was it would be a finite course, and we'd be done. So I had it for six months, and then for 17 years I had nothing. So that weighs into it as well, right, Dr. Allan? Is, what are your goals of treatment? Correct?

Dr. Allan:

Exactly. And I was kind of touching on that a little bit is that I think when we are moving forward, if someone is young and they don't want to be on a potential continuous therapy, because that's the current paradigm of how we're using BTK inhibitors. I think this hypothetical risk of COVID-19 and the SARS-CoV-2 out there, we can't be so shortsighted on saying, "Oh, I'm going to make a decision based on this potential next one to two years of time," when we don't have any evidence that certain therapies may be putting you at risk for severe complications.

And so, again, I think it's patient-specific. I think it's region-specific. I think it's really how well the hospital is equipped at controlling a disease within it. And so I wouldn't say that you can't do those. And I think just because coronavirus is out there, I don't think should weigh that much into swaying, "Oh my God, I don't want something that I'm going to come in on a weekly basis for the venetoclax or whatever it is. And I think we can do these safely, but again, patient-specific, region-specific, hospital-specific, and really the comfort levels of informed consent about what's out there and knowledge of where we stand with the coronavirus. Because, unfortunately, this is going to be a slow simmer until there's a vaccine potentially. And I don't see it going away anytime soon. And as long as we can control, and as long as we can understand risk factors that put people at severe complications, then we will be able to better tailor the treatment for that patient if they are at risk for some of these risk factors that put them at risk for these severe complications.

Andrew Schorr:

Well said. Dr. Thompson, a question from the audience. We've touched on research, Dr. Allan did, and you did. So we've been telling all our audiences, Jeff does it all the time, have clinical trials be put on the table as part of your full range of options, approved therapies, and trials, and have a discussion with leaders such as yourselves, where does this fit in? So should someone hesitate to be in a clinical trial now? You said they're moving forward, or can that be like we said, that it used to be put everything on the table, including trials and make a broad decision?

Dr. Thompson:

I think that there's not a reason not to be on a clinical trial at the moment. Sometimes being on a clinical trial means you may have to come to the hospital more often. And so you have to have that conversation with the patient. And the patient has to understand one of the potential benefits of being on a clinical trial versus the standard treatment options that they may have. In some situations, the potential benefits from being on a trial may be very large. For example, if you run out of standard treatments and you're talking about being on a CAR T compared to a patient who maybe has untreated CLL, where there are lots of good standard of care options. That said, certainly there are some very interesting frontline treatment options that we have on clinical trials that are not available yet for the standard of care, new combinations and things.

So it's just a conversation that the patient has to have with their physician. They need to ask the physician, "Okay, what do you think the benefit of being on the clinical trial may be compared to standard treatment? And is that worth any kind of additional risk associated with more frequent visits to the center?"

Andrew Schorr:

Right. But we should mention, and I think your colleagues have told us, you're doing a lot more via telemedicine or sometimes sort of ancillary tests. If they do come from a distance, they're from outside Manhattan, for example, where you are, Dr. Allan, or at a distance from Houston. That’s sometimes coordinated with a community oncology clinic, a Quest or LabCorp test center, or something like that, you can get data that you need as part of your trial. And I think some of the protocols for trials have been liberalized some to allow for that. So we can discuss that.

Here's another question from the audience for you, Dr. Allan. So related to a COVID-19 vaccine—when it's developed, and we hope there will be, what do we know about, do we know, it's okay if you don't, how it'll interface with somebody with CLL and this whole idea that we went through with the zoster vaccine (Shingrix) and all that, a killed virus? So can you talk to us a little bit about that? Just what we know or how we're going to find out.

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