Tag Archive for: UC San Diego Moores Cancer Center

Developing CLL Research and Treatment News

Developing CLL Research and Treatment News from Patient Empowerment Network on Vimeo.

CLL expert Dr. Michael Choi provides his perspective on the goals of current CLL clinical trials, discusses approved inhibitor treatments, and shares credible resources to keep up with the latest news in research.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

See More from CLL Clinical Trials 201

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Hesitant to Participate in a CLL Clinical Trial_ What You Should Know

Hesitant to Participate in a CLL Clinical Trial? What You Should Know

Clinical Trials As a CLL Treatment Option: What You Should Know

How Does Patient Clinical Trial Participation Move CLL Research Forward

Transcript:

Laura Beth:

Dr. Choi, are there recent advances in CLL treatment and research that you are excited about?  

Dr. Choi:

There’s certainly a lot to be excited about as far as new treatments or new understanding of our treatments. What I see as kind of two main aims of trials right now for our patients with CLL, one is to figure out the optimal way to treat patients, especially in the first line of treatment.  

For the past few years, we’ve had two very clear options, two very clear standards, a BTK inhibitor or the combination of venetoclax and a CD20 antibody. And so, right now, there are a couple of trials both in the states and internationally that are for the first time really comparing those head-to-head. At UCSD, we’re eagerly hoping to join one of those trials as well, and so this will help us and help our patients kind of really know which of those options make the most sense for maybe different subgroups of patients.  

I guess the other main emphasis is to have new therapies available to patients in case these existing standards stop working. And fortunately, this is not a common occurrence. Resistance to BTK inhibitors and Bcl-2 inhibitors is not common, fortunately. But we have to be ready with something if that does occur for our patients.  

Certainly, there’s a lot of enthusiasm for the next generation of BTK inhibitors, cellular therapies like CAR-T therapy, and other classes of medications. So, while I hope most of my patients never need those drugs or never need those trials, I think it’s important that we have those available.  

Laura Beth:

How can patients keep up to date on developing CLL research?  

Dr. Choi:

Oh, that’s a great question. I guess I sometimes ask that same question of myself. How can I stay updated on all the developments and discoveries. Yeah, I guess, yeah, certainly talking to your doctors about what other options there may be. Sometimes, that’s maybe the simplest question to ask.

Yeah, I wish online things were a little bit more straightforward. When I go onto clinicaltrials.gov, I pull up hundreds of different CLL trials, some that might not be relevant for all of my patients. I think The Leukemia & Lymphoma Society and other societies and your group as well have done a great job communicating what some of the most promising areas of research are.  

Hesitant to Participate in a CLL Clinical Trial? What You Should Know.

Hesitant to Participate in a CLL Clinical Trial? What You Should Know. from Patient Empowerment Network on Vimeo.

What should patients know about clinical trials? CLL expert Dr. Michael Choi explains patient trial opportunities and provides key questions to ask about clinical trial participation.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

See More from CLL Clinical Trials 201

Related Resources:

Why Should CLL Patients Consider Participating in a Clinical Trial?

A CLL Expert Addresses Common Clinical Trial Misconceptions

How Is a Patient’s Safety Monitored in a CLL Clinical Trial

Transcript:

Laura Beth:

Dr. Choi, what would you say to someone who is perhaps a little hesitant to participate in a trial to encourage them to learn more?  

Dr. Choi:

Yeah, certainly, it’s very natural to be anxious and to be hesitant about entering into a clinical trial about volunteering to receive something that maybe hasn’t been fully tested before. You know, I think when I talk to my patients about trials, one thing I try to keep in mind is that ultimately, to a degree, to a large degree, we have our trials for our patients. We want to have our trials open at our center so that patients that can benefit from them can have access to them.  

And so, a lot of trials are really kind of designed in that way, to give patients a chance at something that we think will be better or a chance to get a drug when other drugs have stopped working. So, I think many clinical trials aren’t really with the thought that we want to prioritize the science and that our patients are just guinea pigs.  

In fact, I think all of us that are treating patients with CLL and being a part of CLL clinical trials, I think we’re really doing our best to prioritize our patients and their health. The trials are really just a part of that. But beyond that, I think maybe the questions that can be asked would be kind of what’s known already about these drugs. 

 Many trials are using drugs that we’ve already used for many years and maybe just using them in a different manner. So, talk to your doctors about what’s already known. Certainly, the question about how will they be monitored, that’s an important question for your team too. And then, certainly, make sure you understand if there are any other options that would be appropriate or good for you and discuss the pros and cons of the trial versus those options. 

How Does Patient Clinical Trial Participation Move CLL Research Forward?

How Does Patient Clinical Trial Participation Move CLL Research Forward? from Patient Empowerment Network on Vimeo.

Chronic lymphocytic leukemia (CLL) expert Dr. Michael Choi shares how clinical trial participation helps advance research and benefit the CLL community.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

See More from CLL Clinical Trials 201

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Why Should CLL Patients Consider Participating in a Clinical Trial?

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Transcript:

Laura Beth:

Dr. Choi, why is patient participation in CLL clinical trials so critical to advancing research?  

Dr. Choi:

Yeah, there’s still so much that we can do better for our patients. We’ve come a long way. I think we have a few – many treatments that we can really count on to work when we need it, but I think we still have a way that we can refine this more, which combination to use, which sequence to use, how long to do the certain treatments, and then, of course, what to do if those treatments stop working.  

So, I think, yeah, trials help us answer these questions in kind of formal manners so that the information can be used to help other patients in the future.   

Laura Beth:

I imagine that trial participation benefits the CLL community as a whole, by helping to move the research forward?   

Dr. Choi:

That’s so right, yeah. I’m always humbled and impressed by, I guess, the selflessness and the bravery of some of our patients, or of all of our patients and their families and their loved ones. Volunteering for a trial is certainly no trivial thing, not a trivial thing. And so, yeah, I think that that realization that by being a part of a trial, they’re not only potentially helping themselves and getting good care but also helping the future patients as well.  

How Is a Patient’s Safety Monitored in a CLL Clinical Trial?

How Is a Patient’s Safety Monitored in a CLL Clinical Trial? from Patient Empowerment Network on Vimeo.

CLL clinical trials have safety protocols, but how are they carried out? CLL expert Dr. Michael Choi explains the frequency of monitoring, what happens if adverse events occur, and the groups that oversee clinical trial safety.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

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Are CLL Clinical Trials Safe?

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Transcript:

Laura Beth:

Dr. Choi, a lot of patients worry about the safety of a clinical trial. They wonder, “Is it safe, or am I going to be a guinea pig?” What is done to help ensure safety for patients when they’re in a clinical trial? 

Dr. Choi:

Yeah, certainly every clinical trial brings with it or introduces some sense of uncertainty.  

After all, that’s why the trial is being done, because we are trying to learn about how effective or how safe or how tolerable a drug or drug combination is. But certainly, trials are designed in a way that prioritize or emphasize the safety and the monitoring of patients. Oftentimes, trials will have very clear guidance on how often a patient will be assessed, sometimes have very clear recommendations about what to do about each individual lab abnormality that may come up, and certainly very clear guidance on how to adjust the dose of the drugs that are being used if there’s any sort of toxicity.  

But yeah, certainly, I can empathize with the concern that something that’s very new, we may be learning at the same time as our patients as far as what side effects may come up.  

But I do want to emphasize that oftentimes, these aren’t total unknowns, that the research that goes into it, a drug or a pathway, even before the trial starts, gives people a good sense of what things to watch for and how safe things may be.  

Laura Beth:

Is there an oversight committee or a safety committee that reviews the safety information of a clinical trial?  

Dr. Choi:

That’s correct, yeah. Behind the scenes, there are, I imagine, kind of armies of people that are eagerly refreshing their screens to see results come in, both out of excitement to see how something is working, but also to make sure that we’re on top of any side effects or any toxicities that may affect other patients on the trial. Very rarely, maybe a patient on one part of the continent has some side effect, and that information is very quickly and formally disseminated to all the other sites.  

Sometimes, that leads to the other sites deciding to halt their enrollment to figure out what happened and prevent it from happening again, or at the very least, know to keep track of that in our other patients as well. So, yeah, definitely people monitoring things and really, with the priority of keeping other patients safe or keeping all patients safe.  

How Are CLL Patients Monitored After a Clinical Trial Concludes?

How Are CLL Patients Monitored After a Clinical Trial Concludes? from Patient Empowerment Network on Vimeo.

What happens after a clinical trial is complete? CLL expert Dr. Michael Choi explains how participants are monitored during clinical trial follow-up.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. More information on Dr. Choi here. 

See More from CLL Clinical Trials 201

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CLL Clinical Trials: What Are the Phases?

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Transcript:

Laura Beth:

Is there follow-up that’s done after a trial concludes? 

Dr. Choi:

Oh, good question. Yeah.  

Yeah, trials are kind of – let me say what – yeah, when a patient goes through a trial, there can be a sense that the trial concludes, perhaps when the treatment is done or at a certain point when a response assessment is made, but oftentimes, it’s important to also continue to monitor patients after those milestones.

Certainly, for some of our drugs, the treatment continues long-term, so even after some statement has been made about a response rate, many patients remain on treatment, and it’s certainly important to see if there are any long-term side effects or any other developments after the end of that initial period.  

 Other treatments, the trial – the treatment may end. An example might be these trials that combine BTK inhibitors and Bcl-2 inhibitors that are typically for a year-and-a-half or so.   

And certainly, for those trials, it’s definitely critical for patients to be followed as part of the trial so that we can get a good sense of how long those remissions are lasting. Also, of course, to see if there are any delayed or long-term toxicities. So, yeah, so oftentimes, being a part of a trial means being followed, being monitored for some time afterwards.  

What Happens in Each Phase of a CLL Clinical Trial?

What Happens in Each Phase of a CLL Clinical Trial? from Patient Empowerment Network on Vimeo.

What are the phases of clinical trials? CLL expert Dr. Michael Choi outlines the research purpose of clinical trials and what happens in each phase.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. More information on Dr. Choi here. 

See More from CLL Clinical Trials 201

Related Resources:

CLL Clinical Trials: What Are the Phases?

 
How Are CLL Patients Monitored After a Clinical Trial Concludes

How Is a Patient’s Safety Monitored in a CLL Clinical Trial

Transcript:

Laura Beth:

Dr. Choi, can you please walk us through the phases of a clinical trial and what happens during each phase?  

Dr. Choi:

That’s a great question. Yeah, historically, trials have been divided into different phases. The way I think of it is when a drug is first being tested, we don’t want to expose too many people to it, because we’re still learning about the right dose and about its safety. And then, as we learn more and more and maybe get some confirmation that it’s doing what it’s supposed to do, then we have bigger trials and eventually, bring in some comparisons to existing standards.  

So, a Phase I trial is usually, I would say, a few dozen patients, getting the drug for the very first time or sometimes for the first time for this diagnosis. Oftentimes, the very first Phase I trials might have a dose escalation component where the first dose or the first group of patients might get a dose that is based on an assurance that it will be – or some confidence that it will be safe and well-tolerated.  

Then, as the trial goes on, a higher dose will be used once we see that the previous doses are safe. Now, sometimes, this dose escalation happens in between different groups of patients, and sometimes, some trials will escalate the dose for even within an individual patient. But the basic idea of it is to start at doses that we think will be safe and then to gradually escalate it, again, prioritizing the safety of the patients.  

I shouldn’t also – although Phase I trials are designed to determine the safety of a drug, there are many Phase I trials that show clinical activity and benefit to the patients, so I don’t think people should be altogether discouraged from enrolling in a Phase I trial either. 

I can also say that some Phase I trials are just looking at a combination of drugs that we have experience with already, but designed or written as a Phase I trial, because we have to confirm the safety of those two drugs. In those trials, the doses might not be that different than what’s used already, and there’s often more expectation of immediate clinical benefit. Phase II trials are where we’re principally looking or usually looking mainly at the response rate or some sort of clinical endpoint, how many patients get into a partial remission, or how many patients get into a complete remission and so on.  

And I would say these are usually our trials that are 20, 30, 50 patients, to that effect. And basically, from that group of patients, we can get a pretty good estimate of how effective a drug or a drug combination may be. And then finally, the third type of trial, Phase III trial, is when a new drug or a new combination is compared directly to a different – to what would be considered the standard of care at the time.  

So, this is a way that we can get more confidence that this new drug is indeed better than what we’ve been doing up until now.  

How Could CLL Patients Benefit From Clinical Trial Participation?

How Could CLL Patients Benefit From Clinical Trial Participation? from Patient Empowerment Network on Vimeo.

CLL clinical trials are an option for patients, but what is the benefit of participating in a trial? CLL expert Dr. Michael Choi shares the impact of recent research developments for patients.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. More information on Dr. Choi here.

See More from CLL Clinical Trials 201

Related Resources:

How Does Patient Clinical Trial Participation Move CLL Research Forward

How Does Patient Clinical Trial Participation Move CLL Research Forward?

Why Should CLL Patients Consider Participating in a Clinical Trial?

Hesitant to Participate in a CLL Clinical Trial_ What You Should Know

Transcript:

Laura Beth:

Dr. Choi, in your opinion, why should a patient with CLL consider participating in a clinical trial?  

Dr. Choi:

This is definitely a time where there has been a lot of recent progress in the treatment of patients with CLL. The drugs that have been developed in the last few years have definitely been advances, have shown that they are both more effective and more safe than the drugs that we had before.  

So, oftentimes, participating in a clinical trial gives our patients access to some very promising therapies before they’re fully available. Certainly, there are some unknowns and still things to learn about these drugs, so one should be – there are safeguards built into these trials, but I’d say the main thing would be getting access to something that may be better than something that we’ve been using in the past. This applies to somebody getting treatment for the very first time where there may be reasons to think that a new drug or a new combination of therapies will have advantages over things that we’ve been using before.  

And certainly, it is relevant to patients where the existing therapies have somehow stopped working where certainly the trials or experimental agents give us or give our patients a chance to get back in remission.