Tag Archive for: CLL research

CLL Clinical Trials: What Are the Phases?

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CLL Clinical Trials: What Are the Phases? from Patient Empowerment Network on Vimeo.

CLL clinical trials have different phases, but what happens in each phase? CLL expert Dr. Adam Kittai explains the goal of each phase in relation to research and patient care.

Dr. Adam Kittai is a hematologist and an assistant professor at the The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Kittai, here.

See More from CLL Clinical Trials 201

Related Resources:

What Is a Clinical Trial and What Are the Phases? 

 Why Should CLL Patients Consider Participating in a Clinical Trial?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

Let’s talk a bit about how trials work, starting with the phases. What happens at each phase?  

Dr. Kittai:

There are actually four phases of clinical trials, although three phases are typically what’s talked about. So, Phase I is when we are first introducing the new medication, the combination, or the old medication in a new scenario for the first time in a human being.  

Phase one encompasses a lot of different things. It could be a first in-human phase one, where we’re giving the drug for the first time in a human being. It could be, as I said, the combination of drugs being used for the first time in a human being. Or it could be that we have this drug that works for this other cancer and we’re trying it out on this new cancer. So, we might have experience with this drug in another scenario, but not in the scenario we’re trying to do.  

And the primary purpose of the phase one clinical trial is to see if it’s safe. So, that’s the primary purpose of a phase one clinical trial – see if this new medication, this old medication in this new scenario, or this new combination is safe to use going forward.  

Katherine:

Right. 

Dr. Kittai:

We are able to see if it works to a small degree in the phase one trial, but typically these trials are very small with somewhere between 10 to 50 patients. And so, it’s hard to know how well this works by looking at such a small amount of patients.  

Once the Phase I trial goes forward, we usually go onto Phase II. So, one of the other points about Phase I is to determine the correct dose. Usually in phase ones, we increase the dose of the drug slowly until it meets some sort of toxicity cut-off for our patients. So, once that dose is discovered, then we move onto Phase II, and Phase II is usually a small study, usually about 50-100 patients where we’re looking at preliminary efficacy, to see if this drug, this new combination, or the drug in a new scenario, is actually working.   

And so, Phase II will tell us we think it’s working and if it looks good in phase two, it gets moved onto Phase III. Phase III is the final part of the drug development, where if it passes Phase III, it usually gets approved by the Federal Drug Administration. And Phase III is usually a randomized trial where you’re giving the new drug, the combo, or the old drug in a new situation, and you’re comparing it to whatever’s used as standard of care in that particular scenario.  

Katherine:

Right. 

Dr. Kittai:

And that’s usually a randomized study where patients are either getting the new thing or the old thing. And then, we’re determining which one works better. Lastly is Phase IV, and this is post marketing. So, after a drug gets approved, the drug company and the FDA requires just a wide scope of just data that’s collected to see how well the drug is working and if it’s safe once it’s brought out to the wider community.  

A CLL Expert Addresses Common Clinical Trial Misconceptions

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A CLL Expert Addresses Common Clinical Trial Misconceptions from Patient Empowerment Network on Vimeo.

CLL patients and care partners often have misconceptions about clinical trials. CLL expert Dr. Adam Kittai addresses common patient questions and concerns about trials.

Dr. Adam Kittai is a hematologist and an assistant professor at the The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Kittai, here.

See More from CLL Clinical Trials 201

Related Resources:

How Can Clinical Trials Be Accessed?

 Why Should CLL Patients Consider Participating in a Clinical Trial?

 Are Clinical Trials Safe?

Transcript:

Katherine:

Right. So, I’d like to walk through a few common questions that patients have about clinical trials. And here’s a concern we received from a patient prior to the webinar. “I’m nervous that I will receive a placebo if I join a clinical trial.” So, first of all, would you define a placebo? 

Dr. Kittai:

Sure. A placebo is usually a sugar pill or something that has no effect. That’s what a placebo is.  

Katherine:

And is it true then, would a patient possibly get a placebo in a CLL clinical trial? 

Dr. Kittai:

Not typically. So, in terms of clinical trials for CLL, we have a lot of treatments that are effective and safe in CLL. And so, we don’t typically design trials where you’re not getting some kind of active therapy. It would be extremely rare, and I don’t know of any trials currently that involve patients getting a placebo for CLL. Because it wouldn’t be ethical for us to enroll a patient on a trial where they would get a placebo instead of active therapy. 

Katherine:

Here’s another question from an audience member, and I think this is probably a common concern for patients. “Is a clinical trial only something I should consider if there are no other options?” 

Dr. Kittai:

So, in my opinion, you should always consider a clinical trial, even if there are other options. And it’s because of those two reasons that I mentioned earlier. Number one, it benefits the CLL community as a whole to participate in the trial so that way doctors and researchers can collect data to improve outcomes for patients with CLL. And also, even though our drugs currently work really well, we don’t know how well they’ll last for, right? So, they still don’t know for certain how long our current drugs are going to work for in the future.  

And we’re always trying to do better. We’re always trying to create some sort of treatment, some sort of treatment paradigm that might be safer, as well as work better, and either of those goals is approvable. All of our drugs come with toxicity, right? And even though they’re really safe and they work really well, we’re hoping to develop something that is even safer and works even better.  

Katherine:

Yeah. It sounds, then, like trials can be considered throughout a patient’s life with CLL. What concerns do you hear from your patients?  

Dr. Kittai:

Yeah, so I think the primary concern I hear about a trial and the difference between going on a trial and standard of care, is that typically for a trial, it does require a little bit more from the patient. Meaning that there’s usually more visits – whether it is to monitor the effect of the new medication or new medication combination on the patient, whether or not it’s affecting their laboratory values or how they’re feeling.  

Or there might be parts of the trial that require invasive procedures. So, for instance, many trials will require bone marrow biopsies where a standard of care won’t. And the reason why the collection of those bone marrow biopsies is important for the trial is to better get an idea of how the treatment is working on a patient’s body.  

So, I think those are the two primary concerns I hear from the patient. Number one, it typically is a bigger time commitment with more visits to the doctor because we have to closely monitor the patients while they’re on trial. And number two is sometimes the trial involves procedures that otherwise wouldn’t be indicated for standard of care.  

Why Should CLL Patients Consider Participating in a Clinical Trial?

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Why Should CLL Patients Consider Participating in a Clinical Trial? from Patient Empowerment Network on Vimeo.

What is a CLL clinical trial, and why should patients consider participation? CLL expert Dr. Adam Kittai explains the purpose of clinical trials and how patients can benefit. 

Dr. Adam Kittai is a hematologist and an assistant professor at the The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Kittai, here.

See More from CLL Clinical Trials 201

Related Resources:

How Can Clinical Trials Be Accessed?

 CLL Clinical Trials: What Are the Phases?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

So, a key part in moving forward with CLL research is clinical trials, right? So, for people who may not know the term, what is a clinical trial? 

Dr. Kittai:

Yeah. So, a clinical trial is an experiment where patients are enrolled to receive a treatment that is either new or new in a new setting – so, an old treatment in a new setting – and we’re looking to see whether or not the treatment leads to improved outcomes for our patients.  

Katherine:

Why would a CLL patient consider participating in a trial? What’s the benefit for them? 

Dr. Kittai:

Yeah, great question again. The benefit of a clinical trial is two-fold. One is that by participating in a clinical trial, we are collecting data to determine what’s best for patients moving forward. So, in a way, by participating in a trial, you’re contributing to the benefit of CLL patients in the future to help us determine what’s best for everybody moving forward. That’s one reason to go on a clinical trial. Another reason to go onto clinical trials is that it allows for access to therapies that may not be available otherwise, which may work better than what we already have and may be safer.  

CLL Research Highlights: What Should Patients Know About?

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CLL Research Highlights: What Should Patients Know About? from Patient Empowerment Network on Vimeo.

What should CLL patients know about recent research updates? CLL expert Dr. Adam Kittai shares recent research highlights, including updates on BTK inhibitors, BCL-2 inhibitors, and monoclonal antibodies.

Dr. Adam Kittai is a hematologist and an assistant professor at the The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Kittai, here.

See More from CLL Clinical Trials 201

Related Resources:

How Can Clinical Trials Be Accessed?

 Why Should CLL Patients Consider Participating in a Clinical Trial?

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

Transcript:

Katherine:

I understand that CLL researchers met recently at the annual American Society of Clinical Oncology meeting, also known as ASCO, to share their research. Are there highlights from the meeting that patients should know about?  

Dr. Kittai:

Yeah, so this time of year, there are two main conferences actually that are very important to the CLL groups at large, as well as the oncology community. So, there’s ASCO and then there’s EHA, the European Hematology Association. And in general, there was a lot of exciting things at both of these conferences. 

In CLL, we have two main treatments that we’re really focused on. One is called the BTK inhibitors, which is ibrutinib, acalabrutinib, and zanubrutinib that you may have heard about. And the other treatment regimen is called venetoclax, and that’s usually paired with something called obinutuzumab. So, right now we’re either using the BTK inhibitors or the venetoclax as our frontline therapies. And typically, when patients progress on either one of those treatments – their disease gets worse – we switch to the other one. 

And so, what I’m getting to be that right now, that paradigm of starting with one therapy – the BTK inhibitors or the venetoclax – and then switching to the other, or vice versa, is being challenged. How that’s being challenged is combining the two medications together to see if combining them together is better than giving them sequentially. So, I think this is the primary research that’s being looked at in the world of CLL and we got some updates to show that the combination of the BTK inhibitors, plus the venetoclax, is looking quite good. It’s looking like it’s inducing deep remissions in some of our patients.  

Some of the challenges here though that we still need to figure out is that a lot of these combinations are leading to more toxicity. So, ultimately, I think we’re going to have a discussion about who is the appropriate patient for the combination, as opposed to giving it sequentially. 

There’s also a lot more research going on, looking at what we call randomized trials, which we’ll get to in a second, to determine if the combination is better than giving it sequentially. Right now, we just have what we call single-arm studies that kind of show safety and how well the trial works. But really, the definitive clinical trials – and once again, we’ll get to this a little bit later – are going to be randomized study where we randomize patients to the combination versus the sequential therapy to determine if doing it together is better than doing it sequentially.  

So, I would say that this new treatment paradigm of combining our two main treatments up front is looking quite good. We’re worried about some of the toxicities when we combine these medications, and we’re still not quite sure if combining them is the right approach, if it actually is superior to giving them sequentially. So, I think that’s the name in research right now for CLL, whether or not combination therapy is better than sequential therapy. The jury is still out, but some of the new data we saw was exciting. 

Katherine:

So, how can patients stay up to date on research like this as it develops? 

Dr. Kittai:

Yeah, great question. So, for one, you can talk to your physician. A lot of the physicians will go to either ASCO or the European Hematology Association and be able to come back with some of this data to share with their patients. And then also, there’s a lot of smaller conferences that local oncologists will go to get highlights from these particular conferences, where they also will come back to the patient to let them know some of this highlighted research. I think that’s probably the easiest way for patients to get access to this research. And Google’s our friend, right? And so, a lot of things are available on Google if you know where to look for them. 

Is the COVID Vaccine Effective for CLL Patients?

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Is the COVID Vaccine Effective for CLL Patients? from Patient Empowerment Network on Vimeo.

Is the COVID vaccine effective for chronic lymphocytic leukemia (CLL) patients? Dr. Paul Barr shares insight about mRNA-based COVID-19 vaccine effectiveness in CLL patients – both for those in remission and those in active treatment.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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An Expert’s Perspective on CLL Research Advances

Transcript:

Katherine:

I understand that researchers have been looking into whether the COVID vaccination is as effective in people with CLL. What can you tell us about that? The research?

Dr. Barr:

Sure. Everyone knew this was going to be an important question. We’ve known for a long time that riff CLL responses to vaccines in general aren’t as good as some of the normal population. So, there’ve been a whole host of studies over the years where patients didn’t quite respond as well to flu vaccines or pneumonia vaccines. Nonetheless, we typically recommend standard vaccinations, because there’s can be some degree of response. And our testing isn’t always perfect in terms of how well vaccines work.

So, when it typically, is felt to be a relatively safe procedure, is something we typically recommend.

More recently, we looked at studies on the shingles vaccine, and actually that works better than perhaps the flu shot, for example. Because patients probably were previously exposed to that virus earlier in life when they get vaccinated. So, recall response, which is a little bit easier for the immune system.

So, that brings us up to the COVID vaccines, which is obviously critically important ever on everyone’s mind. And the data’s still early. But what we’ve learned so, far is that, like what we might have predicted, our patients, the CLL patients don’t respond as well to the mRNA-based COVID vaccines.

So, in the media we saw, in the larger 20- and 40,000 patients studies that maybe, 95 percent of patients didn’t experience infection. It looks like in the general population, those vaccines work very well. In a cohort of 160, some CLL patients who are vaccinated early on in Israel, it looked like maybe about 40 percent of patients responded.

For the patients who hadn’t previously been treated but had measurable CLL, maybe about half of patients responded adequately in terms of generating antibodies. So, kind of a flip of a coin. For patients who have been treated and were in remission for more than a year, we’ll say the responses were better, maybe 80 percent or so.

For patients who are on active treatment, even our novel treatments, like the BTK inhibitors or venetoclax (Venclexta), the BCL-2 inhibitor, the responses were pretty poor, 18 or so percent.

So, you can see for patients with active disease, their responses are impaired. For those that are in remission, a little better. For those who are on active treatment, the antibody responses aren’t very good. So, I honestly think this is important information, but tell patients, don’t lose hope.

It’s still important to take the precautions. Some degree of wearing masks and social distancing. They will be better protected if their friends and family around them are vaccinated, and they still may respond to some degree. It’s not like the vaccines aren’t working at all. It’s just that the responses aren’t quite as good as the general population. So, again, another long-winded answer, but hopefully that helps patients understand some of the limitations in vaccinations.

But also that generally things are getting safer in that they still can venture out in society, but still have to take some precautions.

What Is a CLL Biomarker?

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What Is a CLL Biomarker? from Patient Empowerment Network on Vimeo.

What is a chronic lymphocytic leukemia (CLL) biomarker? Dr. Paul Barr provides the definition of a biomarker and explains how they may assist in determining a CLL patient’s prognosis and treatment approach.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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An Expert’s Perspective on CLL Research Advances

Transcript:

Katherine:

Often patients are confused with the term biomarker or biomarker testing. Would you define that for us?

Dr. Barr:

Sure. Biomarkers, I think of them as surrogates to understand the bigger picture. A lot of times what we really want to know when we’re meeting a patient is what’s going to happen in the future? What’s going to happen in five and 10 years from now? Or maybe we want to know as we’re getting closer to treatment, how well is this going to work and how long is it going to work for?

So, we do a lot of research in developing surrogate tests to try to give us an idea of what the future might hold. And so, we have developed a number of molecular genetic tests that we test for, and they give us an estimate of what to expect in terms of the patient’s prognosis.

Or perhaps they help predict for which treatment might work best. So, we often, will look at some molecular aberrations or some genetic tests that tell us about abnormalities just within the CLL cells in the leukemia cell. And they can predict for more slowly or rapidly growing disease. And other tests, might predict for, which drug might serve a patient best in terms of efficacy or how long would it work or for safety.

So, think of that as useful tools to help us give the patients an idea of what to expect over time.

An Expert’s Perspective on CLL Research Advances

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An Expert’s Perspective on CLL Research Advances from Patient Empowerment Network on Vimeo. 

What chronic lymphocytic leukemia (CLL) research advances have emerged recently? Dr. Paul Barr shares how CLL treatments have advanced in recent years and how progress has impacted quality of life for patients.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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CLL Treatment and Research Update: News From ASCO 2021

Transcript:

Katherine:

What are you excited about when it comes to CLL research?

Dr. Barr:

Well, it’s hard not to be excited, honestly. Five years ago, roughly, we were largely using chemotherapy.

And while patients could do very well, not all of them did. And in such a short period of time, everything has been turned on its head. We have better treatments for safer, patients are doing better, they’re living longer. There are more novel treatments being studied now. And we start to wonder if with some of the newer treatments, if maybe we actually can cure this disease. Maybe if the majority of them, they might be able to live a normal lifespan. So, we’re incredibly optimistic.

Those are very general statements, but they really are, they come from just the impressive outcomes that we’ve seen from patients being able to be at home, take their treatment, go into deeper remissions and do better in the long-term.

So, yeah, there’s a lot to be excited about. And that’s why my answer is just kind of general. There’s a lot to focus on, from the different novel agents to MRD-guided therapy, to some of the CAR-T products that are coming out. I really think it’ll continue to change at a pretty rapid pace.

Katherine:

That sounds very promising. When it comes to new developments in research, how can patients discuss this type of information with their doctor to find out if there’s a new approach or a clinical trial that might be right for them?

Dr. Barr:

Well, I honestly think they should feel empowered to simply ask. I know a lot of my patients they will want to know anything new. They can ask us, generally is that, they know that we have these major meetings twice a year. And what’s new with these treatments. Or many of them are on clinical trials and want to know, “Do we have any results yet? What’s been changing?” And sometimes at the end of every visit, we’ll spend five minutes just talking about the new developments or what’s coming down the pike or how practice is changing.

I’m just in the routine of having this conversation with most of the patients on a recurring basis. And honestly, they feel well-served, like we’re keeping them up to date. I think patients enjoy that sort of conversation. So, I wouldn’t feel shy about simply asking.

How Can You Engage in Your CLL Care?

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How Can You Engage in Your CLL Care? from Patient Empowerment Network on Vimeo.

How can chronic lymphocytic leukemia (CLL) patients become more engaged in their care? Dr. Paul Barr explains steps that patients can take to activate shared decision-making with their provider for optimal care.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

See More from Engage CLL

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An Expert’s Perspective on CLL Research Advances

Transcript:

Katherine:

We’ve been hearing a lot about shared decision-making lately. In your opinion, how is this concept best put into practice?

Dr. Barr:

So, I honestly think shared decision-making is not just useless term. This is something we actually really use in our clinics, and it’s very important for the care of CLL patients, where we have patients who do very well for a long period of time. And there are a lot of different management decisions and a variety of treatment options that we have to discuss.

So, when we have that luxury, it’s really important to help educate patients on the different options and to better understand what their goals of care are, so they can help us decide what’s best for them. When we’re deciding just, one example is that, when we’re deciding on various treatments, we can use agents that are given orally, taken at home, but patients may be on them for many years.

Alternatively, we have fixed duration regimens, but may involve trips to the infusion center. And a lot of these different treatments all work very well. So, involving the patient in that decision making process, makes the process that much easier for the patient and enables you just to take better care of them over the long run.

Katherine:

What is the role of the patient to making treatment decisions?

Dr. Barr:

Well, I think that the role of the patient is really to be their own advocate. Take all the information and then, help us make decisions together. And to just be very honest about what they want from, not just a simple decision about a treatment, but from their overall care. To really just to be as involved as possible and to make sure all of their concerns are heard, all of their questions are answered.

Katherine:

For those who might have trouble speaking up for themselves, what advice do you have for them?

Dr. Barr:

Oh, I would say, especially for our patients with CLL, often there are many,

many appointments along the way, where there may not be urgent decisions being made and there are opportunities to slowly learn more to ask questions. So, as much as possible, try not to be intimidated by that visit to the cancer center, which obviously can be anxiety provoking, but to develop a relationship with your hematologist, your oncologist, your care team so, that they can take better care of you.

I honestly think it works best when you slowly get to know your team, understand the field, some of the decisions that need to be made and that the team only wants what’s best for you. So, yeah, I honestly think it’s – think of it as a process. It’s not a one-time visit where you have to get everything out and get everything answered. It should be a relationship.

CLL Treatment and Research Update: News from ASCO 2021

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CLL Treatment and Research Update: News from ASCO 2021 from Patient Empowerment Network on Vimeo. 

What’s the latest chronic lymphocytic leukemia (CLL) treatment and research news out of the American Society of Clinical Oncology (ASCO) 2021 meeting? Dr. Paul Barr shares study results and explains how they could impact CLL care.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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An Expert’s Perspective on CLL Research Advances

Transcript:

Katherine:

I’m Katherine Banwell, your host for today’s program. Joining me is Dr. Paul Barr. Dr. Barr, would you please introduce yourself?

Dr. Barr:

Sure. Hi, Paul Barr from the University of Rochester. Glad to be here.

Katherine:

Thank you so, much. Cancer researchers came together recently to share findings at the annual American Society of Clinical Oncology meeting, also known as ASCO. Is there news from the meeting that CLL patients should know about?

Dr. Barr:

There is. It seems like at every major meeting, we have a potentially practice-changing dataset that we like to scrutinize and talk about. This ASCO is no exception. I think probably the most impactful abstract was a report.

The first time we’ve seen the results from a study that was called The ELEVATE Relapsed Refractory Study. This was a randomized trial, enrolling previously treated CLL patients who had high-risk disease and randomizing them to two of our very important BTK inhibitor treatments.

Half the patients got acalabrutinib (Calquence), and the other half received ibrutinib (Imbruvica). And both groups were treated until the drug essentially either stopped working, the disease became resistant or was stopped for side effects. So, this was a study we have waited on the results for a long time given that we don’t often see these randomized studies comparing two such active agents. And the results showed us that both drugs work really almost equally as well.

The progression-free survival or the roughly the average amount of time patients are taking the drug was just over three years, 38 months in both arms. So, they really work very well and equally as well. But we did see less side effects with the acalabrutinib. And one of the most important side effects that the study was powered around was, atrial fibrillation or flutter.

There was less AFib or less new AFib in patients that were treated with the acalabrutinib. There was also less minor bleeding, arthralgia, diarrhea. So, a number of, perhaps less severe type side effects, were less common. There was more headache and more cough in the acalabrutinib-treated patients. But I think overall, most of us took from this abstract that both drugs work exceptionally well.

And overall, are very well tolerated treatments although there does look to be lower rates of a number of important side effects with acalabrutinib.

Katherine:

Dr. Barr, is there any other news from the conference that patients should know about?

Dr. Barr:

There is. I’ll give you a couple other additional findings. One was an update of a study, we’ve seen the results before. It’s sort of a partner study to the one I just mentioned. It was called The ELEVATE TN or ELEVATE Treatment Naive Study.

These were previously untreated patients, treated with an old standard, randomized study where the patients received either chlorambucil-based therapy (Leukeran). It was combined with a CD20 antibody obinutuzumab (Gazyva). The second arm was single agent acalabrutinib and the third arm was acalabrutinib plus obinutuzumab. Not surprisingly both of the acalabrutinibs continue to perform very well. The treatments work much better than chlorambucil. But now, we have four-year data. And that’s important for us to really understand what to expect as time goes on.

And I think that the major take-homes are that, acalabrutinib continues to work very well in the first-line setting. There is a hint that acalabrutinib, I’m sorry, that obinutuzumub may prolong the remissions, which is a little bit surprising to us.

But again, small differences in the study weren’t powered to really look at that comparison. And also, the major take home from that dataset is that the safety still looks very good at four years for the patients receiving acalabrutinib. So, I think that continues to shape our practice. And I think the last dataset or abstract to comment on, was one actually we saw at a different meeting at the European Hematology Association meeting, EHA. And this was another randomized study comparing two different BTK inhibitors in relapsed CLL patients.

This one compared ibrutinib and zanubrutinib (Brukinsa). Like acalabrutinib, zanubrutinib is another more specific BTK inhibitor. And when you compare it to ibrutinib and perhaps somewhat similarly to The ELEVATE Relapsed Refractory Study in this zanubrutinib-ibrutinib comparison, so-called ALPINE study, we saw similar efficacy.

Zanubrutinib actually looked like it performed a little better than ibrutinib, but also again here, lower rates of side effects. So, the theme continues for the more specific BTK inhibitors. They seem to work just as well, maybe a little better in some respects, compared to Ibrutinib and somewhat lower rates of side effects. So, when you put it all together, all of the BTK inhibitors work exceptionally well.

We have varying degrees of follow-up and confidence. We have the most follow-up in our ibrutinib treated patients so, we know what to expect for patients six, seven years out after being on ibrutinib.

But we’re now seeing in these earlier studies that lower rates of various toxicities for the newer more specific BTK inhibitors. So, kind of a long-winded answer to your simple question, but hopefully that shows how the new and emerging data continues to shape how we take care of patients.

Recent Developments in CLL Treatment and Research

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Recent Developments in CLL Treatment and Research from Patient Empowerment Network on Vimeo.

What are the latest developments in chronic lymphocytic leukemia (CLL) treatment and research? Dr. Matthew Davids summarizes the latest treatment news and goals of the treatments – and shares CLL resources for patient care.

Dr. Matthew Davids is Director of Clinical Research in the Division of Lymphoma at Dana-Farber Cancer Institute. Learn more about Dr. Davids here.

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Who Is on a Patient’s CLL Care Team?

Transcript:

Katherine:

Have there been any recent developments in CLL treatment and research that patients should know about?

Dr. Davids:

Yeah. We could spend a few hours on this, but I’ll try to summarize it. There are a lot of exciting developments in the field. I would say at a high level obviously, over the last decade the entire field of CLL treatment has been transformed. Whereas we only had chemotherapy-based approaches before, now we have a whole number of different drugs that we call novel agents. And the reason why their novel is that they target the CLL cells, but they spare the other cells in the body, so there’s less collateral damage there. What that means is that they have fewer side effects, and they’re more effective, so it’s really a win-win situation for patients.

There have kind of been two main approaches for this.

One is to start a novel agent drug and to continue it for as long as it’s helping, which fortunately for most patients is a long time, many years. And then, a newer approach is actually to do what’s called time-limited therapy where you start usually at least a couple of these different novel drugs together but hopefully achieve what we call a very deep remission, meaning excellent shrinkage of lymph nodes and improvement of blood counts and bone marrow disease. And by getting these very deep remissions the idea is we can do a finite period of treatment, whether it’s one year or two years, it kind of depends on the regimen. And then, stop therapy and hope that patients can then enjoy many years of remission while off therapy, which can be nice in terms of reducing side effects and costs and all these other things.

So, those are the biggest developments in the field right now, the continuous novel agent therapy and time-limited novel agent therapy. And a lot of the clinical trials that are getting off the ground now are starting to compare these two strategies to figure out really what’s the optimal way to treat CLL patients.

Katherine:

How can patients stay up-do-date on developments like these?

Dr. Davids:

It’s definitely challenging. It’s challenging even for us who are in the field to keep up with things on the academic side. I think for patients, seeking out patient-friendly sources of information on the web are helpful, but sometimes it can be hard to know what’s reliable information on the web. So websites like this and programs like this I think can be very helpful. Another resource that a lot of my patients find helpful is the CLL Society, so www.cllsociety.org. Brian Koffman really curates a lot of the new developments in the field on that website nicely. He interviews a lot of different CLL experts in this short format that can be very digestible for patients. Patient Power is another great website. So, there are a bunch of them out there, and I think those can be a great resource for our patients.

How Can Patients Learn About Developing CLL Research?

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How Can Patients Learn About Developing CLL Research? from Patient Empowerment Network on Vimeo. 

Dr. Danielle Brander explains why it’s important for chronic lymphocytic leukemia (CLL) patients to stay up-to-date on developing research and treatment news. Dr. Brander also shares resources for learning more about clinical studies.

Dr. Danielle Brander is Director of the CLL and Lymphoma Clinical Research Program at Duke Cancer Institute. Learn more about Dr. Brander here.

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Transcript:

Dr. Brander:

I think it’s very important that patients and their caregivers stay informed and advised of opportunities to participate in ongoing research. I think there’s a misconception that with all the favorable progress in treatment options available for CLL, that there’s no longer the need for clinical research participation.

Though, there are a lot of novel options available for CLL, there’s still a lot of ways that we can improve care for patients. That is, there are trials with the next-generation inhibitors or for patients traditionally with harder to treat CLL or may become resistant to the novel agents, there’s a lot of trials looking into how do you combine the novel agents to give patients the best options. And then a lot of the research, too, are not just in the treatments.

But as our science advances into looking at other markers of the CLL cells, or what we call the depth of response, how much CLL you kill with the treatments and how low of a level we can get in terms of detection. This may result in a situation where patients have the opportunity to receive novel treatments, have a really good response, and then potentially stop the treatments and be followed off of therapies, so have the benefit of novel treatment but not with having to go on an ongoing drug forever and ever.

When I talk to a patient about opportunities for clinical trials, I’m really focused on the patient in front of me. That is, I wouldn’t offer or talk about a trial if I didn’t think it potentially could benefit the patient in front of me.

And again, though we’ve had a lot of advances in treatment options, there are certainly a lot of ways that we can engage and hopefully help patients moving forward. There’s been recent studies across all cancers showing that unfortunately a very low percent of patients are offered and enrolled and participating in clinical research studies, and I think it’s really important that patients know there’s a lot of opportunities out there that potentially could benefit them.

The different ways to be advised and informed, again, are some of the resources online educationally for CLL and lymphoma that often post about different sites for clinical trials. There’s a clinical trials.gov web site that all sites in the United States that are enrolling trials with patients have to log clinical trials, and though that has to be updated, it often can be a good beginning site.

But in the end, hopefully the best resource is your treatment team, your oncologist, and your other team that can help point you to what trials might be eligible for you, either at the location where you are or close by.

The last part I’ll point out is though we focus a lot on the treatment clinical trials, in CLL, where patients don’t always need treatment right away or may have treatment and have a response and then have a long period of time afterward, is that many centers are helping to engage patients in research that is not necessarily done during the time of their treatment. Again, to try to understand why some patients have a longer course until they require treatment, or why they might have responded differently, or other ways we can improve their care.