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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.

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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.

Are There CLL Clinical Trials Studying Richter’s Transformation?

November 22, 2022/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Thrive, CLL Thrive Understanding, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC /by Kara Rayburn

Emerging CLL Treatment Approaches

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Are There CLL Clinical Trials Studying Richter’s Transformation? from Patient Empowerment Network on Vimeo.

Have there been any advances in treating Richter’s transformation in chronic lymphocytic leukemia (CLL) patients? Dr. Seema Bhat discusses emerging approaches.

Dr. Seema Bhat is a hematologist at The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Bhat here.

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Transcript:

Katherine:

Sophia wants to know, “Are there any clinical trials regarding Richter’s, or DLBCL, transformation?”

Dr. Bhat:

So, Richter’s transformation means when CLL, which is a low-grade disease, changes into high-grade lymphoma, and most commonly it’s “diffuse large B-cell lymphoma,” or DLBCL. Currently available treatments for Richter’s transformation are, unfortunately, sub-optimal. So, clinical trials to find better treatments are critical for this division, and there are a number of these currently going on. For example, some trials add targeted agents to the backbone of standard chemotherapy called, “R-CHOP.”

So, we have one trial where acalabrutinib is being added. There’s another clinical trial where venetoclax is being combined with R-CHOP. One of the problems with Richter’s transformation is that it tends to be refractory to treatment, and it tends to come back or relapse. So, there are studies ongoing for relapse treatment as well, with combination of targeted agents. And CAR-T therapy, we just talked about that, is also being studied in Richter’s transformation. So, there’s a lot going on to improve the outcome for this.

CLL Research Highlights: What Should Patients Know About?

August 3, 2022/in Chronic Lymphocytic Leukemia, CLL CT 201, CLL CT 201 Benefits, CLL Newly Diagnosed, CLL Programs, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC /by Kara Rayburn

See More from CLL Clinical Trials 201

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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.

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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.

Exciting Advances in Waldenström Macroglobulinemia (WM) Treatment

June 23, 2022/in NHL Treatments and Clinical Trials, NHL Videos TC, Non-Hodgkin's Lymphoma, Waldenstrom, Waldenstrom Treatment and Clinical Trials, Waldenstrom Video TC, Waldenstrom's Programs, Waldenstrom's Toolkit, Waldenstrom's Treatment TK /by Kara Rayburn

Emerging Waldenström Macroglobulinemia Treatment Approaches

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Exciting Advances in Waldenström Macroglobulinemia (WM) Treatment from Patient Empowerment Network on Vimeo.

What new therapies are on the horizon for patients with Waldenström macroglobulinemia (WM)? Dr. Shayna Sarosiek from Dana-Farber Cancer Institute reviews promising developments in WM treatment, including immunotherapy and BTK inhibitors.

Dr. Shayna Sarosiek is a hematologist and oncologist at the Dana-Farber Cancer Institute where she cares for Waldenström macroglobulinemia (WM) patients at the Bing Center for Waldenstrom’s. Dr. Sarsosiek is also Assistant Professor of Medicine at Harvard Medical School. Learn more about Dr. Sarosiek, here.

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Transcript:

Katherine:

What are you excited about when it comes to Waldenstrom’s research?

Dr. Sarosiek:

So, there a couple of things that I find really exciting right now. One thing in particular is currently for treatment for Waldenstrom’s, we often use BTK inhibitors. So, the group of medications that includes zanubrutinib (Brukinsa), ibrutinib (Imbruvica), acalabrutinib (Calquence). And that class of medications has really revolutionized treatment for Waldenstrom’s. But sometimes patients become resistant to those medications. And there’s a new group in that same class of what’s called BTK inhibitors.

And those are non-covalent BTK inhibitors. And those drugs actually work often for patients who progress on initial therapy with ibrutinib or zanubrutinib. So that really, I think is game changing. There are some early Non-Covalent BTK inhibitors that are in trials. And I really think it’s going to lead to use of those medications very commonly in the future for Waldenstrom’s. So, that I think is exciting to have a next oral therapy to go to after progression on the current therapies. I’m also excited about new combinations that are being tried in Waldenstrom’s.

So, using combinations of different oral therapies together that would offer deep responses and also offer a time-limited therapy. Because right now many of our treatments are given indefinitely. And so, offering a limited therapy. So, I think that, and there are many other things I could go on for a long time about this. But there are many things that I think are really exciting and we’re going to be changing the field in the coming years.

Katherine:

Dr. Sarosiek, what is immunotherapy? Could you define that and also, how does it work to treat Waldenstrom’s?

Dr. Sarosiek:

So, immunotherapy includes many different types of medications. But these are all medications that either use the patient’s immune system or use something from the immune system, like an antibody to help fight off a cancer. And this plays a huge role currently and I think it will continue to in the future. So, probably the most common immunotherapy that patients are familiar with, with Waldenstrom’s now is rituximab (Rituxan). So, that’s a monoclonal antibody.

And that’s used in many combinations in Waldenstrom’s and is a very important therapy currently. And that antibody is essentially just goes into where the cancer cells are located and attacks that type of cell.

But the other immunotherapies that are up and coming – which I think are important for patients to know about – one is CAR-T cell therapy. So, a lot of patients ask me about that. and that’s essentially, a T cell is part of the immune system that every patient has. And what CAR T-cell therapies do is patients can collect from their bloodstream – the physicians can collect T cells and then they modify those T-cells in a way so that they’ll recognized the cancer and attack the cancer.

And so then, those T cells are given back to the patient and then that T cell can go and work with the patient’s immune system to destroy the cancer. And that’s been very successful in a lot of other cancers and is being used in Waldenstrom’s now. And I think we’re going to be learning a lot about that and it’s going to be an important part of the future with immunotherapy involved in Waldenstrom’s. Another therapy similar is something called BiTE therapies. So, Bispecific T-cell engagers.

So, that’s essentially two antibodies together. One antibody kind of pulls in the cancer cell and one antibody pulls in the immune system. So, when that treatment is given to patients it kind of brings the immune system close to the cancer cells. So, your own immune system can help fight off the cancer. So, those are just kind of two of the newer immunotherapies that are up and coming that I think will play an important role in the future in this disease.

Katherine:

Who is this treatment right for?

Dr. Sarosiek:

Immunotherapies in general currently we’re using them – currently immunotherapies are being used in patients who have had a relapsed disease. So, they have already had current available therapies, like BTK inhibitors or rituximab. And there are clinical trials that can use CAR-T cell therapy. And there are up and coming trials with BITE therapy. So, right now it’s being used in their relapse setting. But as we learn more about it, it’s possible those we moved earlier on to patients who are earlier in their disease course.

Katherine:

What kind of side effects should patients be aware of?

Dr. Sarosiek:

So, the side effects can vary depending on what the therapy is. So, patients who are getting rituximab, the currently available immunotherapy, patients can have infusion reactions. So, as your body is kind of getting used to that monoclonal antibody coming in, you can have a reaction. And in that case, we have to stop the infusion, wait for the side effects to settle down, and then restart.

Katherine:

What type of side effects would they be?

Dr. Sarosiek:

So, side effects from rituximab infusions can really vary. In some patients it can be similar to an allergic reaction. So, let’s say itchy throat or a rash or hives. Sometimes it can be pain in the chest or the back or trouble breathing. So, they can really vary. But most of the time, those can – when the infusion is stopped, we can give patients medications like Benadryl or Tylenol to help with symptoms. And then we can restart the Rituximab at a lower rate. And that lower rate allows the patient’s body to kind of get used to the medication and continue on the treatment. So that’s generally the things we watch for with Rituximab.

CLL Treatment and Research Update: News from ASCO 2021

July 15, 2021/in Chronic Lymphocytic Leukemia, CLL Engage, CLL Engage Treatment, CLL Newly Diagnosed, CLL Programs, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC /by Kara Rayburn

How Can You Engage in Your CLL Care?

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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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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.

What is High-Risk CLL and How Is It Treated?

May 14, 2021/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC, INSIST! CLL, Treatment Decisions /by GIna Craig

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What is High-Risk CLL and How Is It Treated? from Patient Empowerment Network on Vimeo.

What exactly is high-risk chronic lymphocytic leukemia (CLL), and how is it treated? Dr. Lyndsey Roeker discusses biomarkers that indicate high-risk CLL as well as treatment approaches that may be used for targeting specific subtypes of CLL.

Dr. Lyndsey Roeker is a hematologic oncologist at Memorial Sloan Kettering Cancer Center. Learn more about Dr. Roeker here.

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Transcript:

Katherine:

We have an audience question. Mike wants to know, “What does it mean to have high-risk CLL?”

Dr. Roeker:

So, great question, and the interesting thing is that I think the answer to that question is evolving. So, deletion of 17p, deletion of 11q, and TP53 mutation have historically been markers of more aggressive disease or unfavorable CLL. In the era where we only had chemo and immunotherapy, we know that patients had less great outcomes. We know that the treatments tended to not work as well, and patients had disease that tended to come back faster, and things like that.

That’s all evolving in the era of targeted agents. We have some indication that probably patients who have more aggressive underlying disease biology, meaning disease that’s going to behave less well, kind of regardless of what we treat it with, certainly may derive less benefit, meaning that the treatment will work for less long. That being said, these treatments are still really effective for our patients who have traditionally high-risk disease. So, I think it still remains to be seen, in terms of long-term outcomes and what to expect for patients that have these traditionally high-risk characteristics.

Katherine:

Let’s run through a few potential results so we can understand how you might approach each patient type. If someone has deletion 17p, what is the approach?

Dr. Roeker:

So, there are two totally reasonable frontline treatment options.

So, BTK inhibitors, which are – the current approved ones are ibrutinib and acalabrutinib, are completely a reasonable approach in the frontline setting, meaning the first treatment that someone gets, and those are pills that you take daily. For ibrutinib, it’s once a day. For acalabrutinib, it’s twice a day, for as long as they’re working. And the idea is, with this approach, you keep on those medicines, and they keep the disease suppressed. So, that’s the first option.

The second totally reasonable option is a combination of venetoclax (Venclexta) and obinutuzumab (Gazyva). So, venetoclax is a pill and obinutuzumab is an IV medicine, and the way that this was studied was a total of one year of therapy. So, from the time you start until you’re done with all of your treatments, that’s a one-year course. And the drugs have different side effect profiles, and depending on other medical problems, patient preference about, let’s just take a pill and that’s easy, versus the combination of pill and IV medicines, either can be a completely reasonable choice.

It just depends a lot on patient and doctor preference.

Katherine:

What about the TP53 mutation?

Dr. Roeker:

So, both of those treatment options seem to work very well for TP53-mutated patients. We had that discussion about the possibility of chemoimmunotherapy for a small minority of patients, and for patients with a TP53 mutation, using chemoimmunotherapy up front is probably not the correct answer. It’s better to go with one of the targeted drug approaches.

Katherine:

How would you approach each patient type, if a patient is IGHV unmutated?

Dr. Roeker:

So, IGHV-unmutated is the same discussion. Chemoimmunotherapy is probably not going to provide a durable, meaning it’s not going to last for a long time. We’re not going to achieve that potential cure. So, for those patients, either the BTK inhibitor approach, or the venetoclax/obinutuzumab approach is completely a reasonable one to take.

Katherine:

And if they’re IGHV-mutated?

Dr. Roeker:

IGHV-mutated patients who are young and don’t have a lot of other medical problems, that’s when we add in the third option of chemoimmunotherapy. For many patients, it’s not wrong to choose either a BTK inhibitor or venetoclax/obinutuzumab, but it does add in that third potential option of chemoimmunotherapy.

Katherine:

Are there other markers that patients should know about?

Dr. Roeker:

So, TP53 mutation status, FISH, and karyotype kind of gets you most of them. Some centers do additional next-generation sequencing of other genes that have been associated with higher-risk disease, though really understanding how to interpret those results still remains somewhat unclear, and that’s still an area of research that people are doing, to really understand what those other mutations really mean for people.

An Overview of CLL Treatment Types

April 13, 2021/in Chronic Lymphocytic Leukemia, CLL Engage, CLL Engage Treatment, CLL Newly Diagnosed, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC /by Kara Rayburn

What Are the Goals of CLL Treatment?

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An Overview of CLL Treatment Types from Patient Empowerment Network on Vimeo.

What are the treatment types for chronic lymphocytic leukemia (CLL)? Dr. Matthew Davids details each type of treatment – and which type of patients some treatments may be most appropriate for.

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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Transcript:

Katherine:

Well, once it’s time to treat, of course, then it’s time to think about treatment options. Let’s walk through the types of treatments that are used today to treat CLL.

Dr. Davids:

As I alluded to before, we historically have had chemotherapy-based approaches to treat CLL. And that was an effective way to temporarily put the disease into remission, but it had a lot of side effects and inevitably the CLL would come back. And the challenge particularly with chemotherapy-based approaches it that when the CLL does come back after chemotherapy, it tends to behave more aggressively and be harder to treat.

So, there have been quite a few studies over the last few years trying to figure out ways that we can avoid using chemotherapy as the first treatment, and this can involve treatments such as monoclonal antibodies. People may have heard of rituximab or a newer drug, obinutuzumab. There are the inhibitors of the B-cell receptor pathway, and this is for example ibrutinib (Imbruvica), which targets a protein called BTK, also a newer one called acalabrutinib (Calquence), which targets BTK. And then, I mentioned at the beginning these fixed-duration therapies that stop after a period of time. Many of those are based on a newer oral drug called venetoclax (Venclexta), which when we give it as a first therapy, we give in combination with that antibody obinutuzumab (Gazyva).

So, a bit of an alphabet soup. I know it gets confusing with all the different treatments, but the good news for CLL patients is, 1.) we have a lot of options, which is great, 2.) we don’t necessarily need to use chemotherapy anymore, and in fact I use it pretty rarely these days. One situation where I do still consider chemotherapy is for younger patients – which in the CLL world is sort of under age 60 or so – if they have very favorable biology to the disease, in particular this mutated IGHV.

That’s a scenario where the older chemotherapy regimen, FCR, can be very effective. It’s a six-month treatment, and we have patients with those molecular characteristics who are now 12, almost 15 years out from their initial six months, and they’re still in a complete remission. So, many of those patients have been functionally cured of their CLL from the six months of treatment. But again, there are some risks to that approach. We worry about other cancers that may be more likely after receiving FCR. We worry about infections, and particularly in the COVID situation, we worry about COVID infection in patients on chemotherapy.

So, it’s been pretty rare that I’ve been using that approach these days. I’ve been opting more for the novel agent-based approaches. So, often now the conversation as an initial therapy comes down to, “Do you prefer more of a continuous treatment strategy with a BTK inhibitor drug like ibrutinib or acalabrutinib, or do you like the idea of a time-limited therapy with one year of venetoclax in combination with obinutuzumab?” And I would say there’s pros and cons to both approaches, and we don’t know which one is the optimal one for CLL patients to start with, but probably I think most patients at some point in their lifetime are going to need one therapy or the other.

So, maybe in the end it doesn’t matter too much which one you start with if you’re going to get both eventually anyway. But we don’t know that yet.

Confusing CLL Terms Defined

November 23, 2020/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Testing, CLL Videos ND, CLL Videos T, INSIST! CLL, Understanding Testing /by GIna Craig

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Confusing CLL Terms Defined from Patient Empowerment Network on Vimeo.

What is FISH testing? What is IGHV? Physician assistant Danielle Roberts explains the meaning of these often confusing terms and their role in disease monitoring and CLL treatment decisions.

Danielle Roberts is a physician assistant with the Bone Marrow Stem Cell Transplant (BMT) team at Winship Cancer Institute at Emory University. Learn more here.

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Transcript:

Danielle Roberts:

So, a FISH test is a test from your either blood in your bloodstream or from your bone marrow biopsy. And it stands for florescence in situ hybridization. And this is a highly specific test that looks at the chromosomal changes with CLL. This can be done in the peripheral blood or in the bone marrow.

And it’s important to remember that when we consider genetic testing and CLL, we aren’t talking about inherited genes, but the abnormalities that occur within the CLL itself.

So, an IGHV test is a mutational test that stands for the immunoglobulin heavy-chain variable gene locus. This can also be done in the peripheral blood and the bone marrow biopsy. This test can help us determine treatment options as well as help with determining what high-risk features there are for your particular disease.

So, 17p deletion is the deletion of the long arm of chromosome 17. This can be seen at initial diagnosis or it can be acquired later on in disease progression. So, for all patients this is one of the more important tests that if you’re going to ask your doctor if you’ve had, you should ask at a diagnosis. If you’ve relapsed later on, you should ask again if that mutational status is being observed or checked in your follow-up testing.

17p deletion is something that can be acquired along the course of your disease progression. It is not always seen at initial diagnosis but can be acquired if you are relapsed or refractory. Therefore I recommend that every time you’re having peripheral blood for flow or if you’re having bone marrow biopsies, especially if it’s for treatment planning purposes, you should advocate to your physician team to make sure that this test is being performed as it will drive – or as it can drive treatment decision-making.

Practical Advice for Coping with a CLL Diagnosis: What’s Next?

November 23, 2020/in Chronic Lymphocytic Leukemia, CLL Advice TK, CLL Newly Diagnosed, CLL Toolkit, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC, CLL Videos WN, CLL What's Next /by GIna Craig

Confusing CLL Terms Defined

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Practical Advice for Coping with a CLL Diagnosis: What’s Next? from Patient Empowerment Network on Vimeo.

After receiving a diagnosis of chronic lymphocytic leukemia (CLL), patients can have a variety of concerns. Physician assistant Danielle Roberts shares her top three pieces of practical advice for patients to move forward.

Danielle Roberts is a physician assistant with the Bone Marrow Stem Cell Transplant (BMT) team at Winship Cancer Institute at Emory University. Learn more here.

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Targeted CLL Therapy: What Are the Side Effects?

Transcript:

Danielle Roberts:

My recommendations if I could have three things that I would recommend all patients with CLL do, 1.) It would be to have your financial information kind of in line or know how to find that. Unfortunately, a lot of the medications that we use to treat disease are incredibly expensive. However, there are really good patient assistance programs out there. In order to be able to apply for patient assistance programs you do have to submit your financial information to them. So, I would really suggest that you have access or be able to know where to find that.

I would also really recommend you talk to your family members in so that they understand what’s – where you are with your treatment and what’s going on. As a physician’s assistant, one of the questions I generally get is when they bring in a family member or somebody who has not been along in their journey for their treatment, if they’re asking lots of questions, that was and kind of diagnosis. So, I encourage people to talk about that at the beginning, so everybody understands where they are and what the plan for the future is going to be.

And then the last thing that I always recommend to everybody is to understand that not one treatment is right for everybody. Understand that things are going to change and we’re all going to grow and we’re going to learn with the process. But if you don’t tell your healthcare team what’s going on, we can’t help you. And we say that there is no such thing as a bad question to us. You’re never bothering us. That’s what we’re here for. Rather you tell us, even if it may be something you feel is minor, ahead of time so that we can address it and work towards a solution, if there needs to be one.

How Could Emerging CLL Treatments Impact Your Care?

November 17, 2020/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC, INSIST! CLL, Treatment Decisions /by GIna Craig

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How Could Emerging CLL Treatments Impact Your Care? from Patient Empowerment Network on Vimeo.

In the changing world of chronic lymphocytic leukemia (CLL) research, how can emerging treatments impact care for patients? Dr. Jennifer Woyach shares information about targeted therapies, immunotherapy and clinical trials, and explains why she is hopeful about the future of CLL care.

Dr. Jennifer Woyach is a hematologist-oncologist specializing in chronic lymphocytic leukemia (CLL) at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute. Find out more about this expert here.

What Does It Mean to Have High-Risk CLL?

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Transcript:

Katherine:

That’s a good point. Are there emerging treatments patients should know about?

Dr. Woyach:

Yeah. There are a lot of really exciting things going on in CLL right now. And CLL is a disease that has been completely transformed in the last five to 10 years and is poised to do so again. So, I mentioned these therapies that we use for frontline treatment, and there are clinical trials now combining them together. So, these agents work so well on their own. Are they going to be even better if we add them together?

There are also newer target therapies, different targets that we are finding increasingly important in CLL, as well as a modality called CAR-T cells, which most people have heard of where we take patients’ own T cells, modify them in the lab and then, give them back with a goal of getting those cells engineered to kill CLL cells.

These are all things that are not ready for prime time in CLL yet but are available in clinical trials. And I think one other thing I’d really like to put a plug in for is clinical trials in CLL, because right now we’re at a point where our therapies are really very good. But if people just do those treatments, we are never going to figure out which one is the best or figure out, for specific types of patients, which treatment is the best. And so, I advocate that any of my patients that are eligible for clinical trials should consider them, because that’s how we make progress in the disease from an altruistic sense.

That’s how we make things better for everybody. That’s one way a patient can think about it. But more personally than that, being in a clinical trial gives somebody the opportunity to get a treatment that they otherwise wouldn’t get that might be better than our standard of care therapies.

Katherine:

Dr. Woyach, as a researcher in the field, why are you hopeful?

Dr. Woyach:

I am so hopeful in CLL because there is so much that we’re learning every day about the biology of the disease, about specific mutations and other genetic factors that are important and really can be targeted by new drugs. Paralleling our understanding of the disease, there also are many more techniques to make these targeted therapies that kill cancer cells selectively while sparing normal cells and making our drugs even more tolerable.

And I think both the targeted therapies like this and the potential of combining them, figuring out sequences that are best but then, also these newer modalities where we, actually, get the immune system involved like the CAR-T cells. They’re making CAR NK cells now. And just lots of other strategies that could be used together with targeted therapies to, hopefully, cure the disease.

Targeted CLL Therapy: What Are the Side Effects?

November 17, 2020/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC, INSIST! CLL, Treatment Decisions /by GIna Craig

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Targeted CLL Therapy: What Are the Side Effects? from Patient Empowerment Network on Vimeo.

What are common side effects of chronic lymphocytic leukemia (CLL) targeted therapies? Dr. Jennifer Woyach discusses side effects of specific targeted therapies and the importance of reporting any issues to your doctor for optimal quality of life.

Dr. Jennifer Woyach is a hematologist-oncologist specializing in chronic lymphocytic leukemia (CLL) at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute. Find out more about this expert here.

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Transcript:

Katherine:

If there are side effects, what would some of the side effects be for these targeted therapies?

Dr. Woyach:

So, it depends on the drug. So, BTK inhibitors, specifically, ibrutinib can cause some joint and muscle pain, some rashes, diarrhea, heartburn. Those are things that tend to, if they’re going to happen, usually happen earlier on in treatment and tend to get better over time. It can also cause high blood pressure. It can cause an abnormal heart rhythm called atrial fibrillation.

So, those are things we watch out for with ibrutinib. Acalabrutinib really has all of the same side effects but for many of them, they don’t occur as often. And then, the tradeoff there is ibrutinib is given once a day and acalabrutinib is given twice a day. With venetoclax plus obinutuzumab with that regimen, you get a lot more hematologic toxicity. So, you see more lowering of the good white blood cell count, which is, obviously, a risk for infections. That regimen comes with a risk of something called tumor lysis syndrome, which is where the cells can break down too quickly and cause damage to the kidneys, damage to the heart.

It can also cause some GI disturbance like some diarrhea, nausea, abdominal pain, things like that. I see there are a lot of side effects. And, of course, when I’m talking to a patient about treatment, we go over them in more detail than that. But I think the important thing is with all of these therapies, we do have ways to manage these side effects.

One thing I think is important for patients to remember is your doctor doesn’t know you’re having side effects unless you tell them. So, we know that people have these side effects. But if you don’t tell us that you’re having diarrhea or heartburn or things like that, we can’t help with it. And we have a lot of medicines that can help these things.

What Is YOUR Role in CLL Treatment Decisions?

November 17, 2020/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Resources ND, CLL Treatments and Clinical Trials, CLL Videos TC, INSIST! CLL, Treatment Decisions /by GIna Craig

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What Is YOUR Role in CLL Treatment Decisions? from Patient Empowerment Network on Vimeo.

What is the chronic lymphocytic leukemia (CLL) patient’s role in making treatment decisions? Dr. Jennifer Woyach explains frontline CLL therapies and how patients help guide the treatment decision that’s best for them.

Dr. Jennifer Woyach is a hematologist-oncologist specializing in chronic lymphocytic leukemia (CLL) at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute. Find out more about this expert here.

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Transcript:

Katherine:

Dr. Woyach, what do you feel is the patient’s role in this conversation about treatment approaches?

Dr. Woyach:

I think that, obviously, the patient is the most important part of the talk of treatment indications. Like I mentioned, sometimes we have the discussion of chemotherapy versus a targeted therapy. More often, the discussion is we have three approved frontline CLL therapies right now. We have two BTK inhibitors or Bruton’s tyrosine kinase inhibitors, ibrutinib, acalabrutinib.

And then, we have a BCL-2, venetoclax, that’s given in combination with an antibody called obinutuzumab. These are very different treatments in terms of side effect profiles, how they’re administered, how often they’re administered, just as an example. The BTK inhibitors are pills. And they’re meant to be given indefinitely. So, you start them with plans that you’re not going to stop them, unless the patient doesn’t tolerate them or they stop working. And so, with that type of regimen, you have the kind of burden of being on treatment for a long period of time.

But on the flipside, it’s very easy to start treatment. So, if you decide you want a BTK inhibitor, I write a prescription for it, it comes to your house, you start it. I usually see patients monthly for the first six months and then, we go to every three months. It’s very easy to start treatment.

The other type of treatment, the venetoclax plus with the obinutuzumab regimen, that’s the BCL-2 inhibitor with an antibody, it’s a finite therapy. So, people are treated for a year and then, they go off treatment. The flipside of that is they’re a lot more time intensive in the beginning. So, you have the IV therapy with the obinutuzumab. Venetoclax you, actually, have to ramp up the dose so patients have to come in weekly for the first five weeks, and they have to come in monthly for their infusions. So, it’s much more time intensive up front but then, you get to stop treatment. And so, those are considerations that I can’t answer for somebody.

I don’t know which one people would prefer and people prefer different things. So, we spend a lot of time talking about all of the different scenarios and what’s going to make the therapy work best for the patient.

Could CLL Be Inherited?

November 17, 2020/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Videos ND, CLL Videos WN, CLL What's Next, INSIST! CLL, Treatment Decisions /by GIna Craig

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Could CLL Be Inherited? from Patient Empowerment Network on Vimeo.

Can chronic lymphocytic leukemia (CLL) be inherited directly from parents? Dr. Jennifer Woyach discusses the likelihood of passing down CLL to children and the difference between genetic mutations and acquired mutations in CLL.

Dr. Jennifer Woyach is a hematologist-oncologist specializing in chronic lymphocytic leukemia (CLL) at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute. Find out more about this expert here.

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Transcript:

Katherine:

We have another question from a patient who wants to know if their children will inherit CLL. Is there any link between inherited mutations and CLL?

Dr. Woyach:

That’s a very, very common and really important question. I would say of the hematologic cancers, CLL is one with higher linkage in families, which means that people with CLL are more likely to have another family member with CLL though it’s still not very common.

And it’s very different from breast cancer or the solid tumors where we know that these specific mutations indicate families that are going to have risk of disease. There has actually been a lot of study over the years of families that tend to have multiple people with CLL. Unfortunately, there really have not been genes identified that are the reason for those family linkages. I think there has been only one family that I know of where they’ve actually found a gene that was likely the cause of multiple family members’ illnesses. So, yeah, there is no indication to test family members.

I tell people do not worry that you’re going to pass this to your children or your grandchildren. CLL is not something that we should be using as like a marker of whether you should have kids or should have anything like that.

So, maybe a little more likely in family members but not enough to really be worried about that.

Katherine:

What are the differences or difference between inherited and acquired genetic mutations?

Dr. Woyach:

So, inherited mutations are those that you get from your parents. And there are lots of inherited mutations that, actually, can predispose to cancer. Specifically, I mentioned the TP53 mutation and CLL cells. Well, there are also people who inherit a TP53 mutation have risk factors for multiple cancers. And CLL, specifically, every mutation that we talk about is an acquired mutation. So, that’s also known as a somatic mutation. So, they’re mutations in the cancer cells. But if you did DNA sequencing of the normal cells, they would not be there.

What Does It Mean to Have High-Risk CLL?

November 17, 2020/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Treatments and Clinical Trials, CLL Videos ND, CLL Videos TC, CLL Videos WN, CLL What's Next, INSIST! CLL, Treatment Decisions /by GIna Craig

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What Does It Mean to Have High-Risk CLL? from Patient Empowerment Network on Vimeo.

What does high-risk chronic lymphocytic leukemia (CLL) mean exactly? Dr. Jennifer Woyach explains the meaning of high-risk CLL, factors in determining disease progression, and the impact on treatment decisions.

Dr. Jennifer Woyach is a hematologist-oncologist specializing in chronic lymphocytic leukemia (CLL) at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute. Find out more about this expert here.

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Transcript:

Katherine:

We have a patient question. I have 17p deletion. Should I be worried?

Dr. Woyach:

So, 17p deletion is usually associated with more aggressive disease biology almost always associated with that unmutated IGHV. The reason I bring that up is there are a very small subset of patients who have 17p deletion and mutated IGHV who, actually, have pretty indolent or slow growing disease.

People who don’t, which is the majority of them with 17p deletion, do have a shortened time to treatment and shortened survival with most of our current therapies. There have been a lot of advances though in the treatment of 17p deleted CLL. And may of our newer therapies can very much prolong the remission time in the lives of patients with 17p deletion.

Katherine:

Dr. Woyach, how do these chromosomal changes affect disease progression and prognosis?

Dr. Woyach:

So, the markers that are associated with more aggressive disease biology usually are going to be associated with people that need treatment within the first few years after diagnosis, especially those people who have 17p deletion, 11q deletion, unmutated IGHV.

Katherine:

What exactly are prognostic factors? Would you define that?

Dr. Woyach:

Sure. Prognostic factors, and I mentioned three of them, the IGHV, FISH, and the TP53 mutation, are ones that have been studied extensively and shown that the presence of this marker or some change in this marker is associated with a change in the biology of the disease or in the response to therapy.

Katherine:

How does the identification of these changes or mutations affect treatment options?

Dr. Woyach:

Well, right now, we’re lucky in CLL because we have a lot of treatment options. I would say the most important changes when we’re talking about somebody with CLL that is about to start their first treatment is the decision of whether chemotherapy is ever appropriate. So, almost everybody with CLL now is treated exclusively with targeted therapies.

So, nonchemotherapeutic options. There are some people who are young, and in CLL terms that means under the age of 65, who have mutated IGHV and who otherwise have good genetic list disease. So, normal chromosomes of the 13q deletion, no TP53 mutation. That small subset of patients, actually, has the potential to be cured with a specific type of chemotherapy. It’s called FCR or fludarabine, cyclophosphamide, rituximab. So, for those young, healthy patients, it’s really important to know those risk factors to know if they are in that group that has that potential for cure.

The converse to that is if patients don’t fall in that group, they probably shouldn’t receive chemotherapy as their first treatment, because it’s not as effective as our other therapies.

Katherine:

Yeah. It makes sense.

Dr. Woyach:

And then, even in the future with first and other treatments with novel therapies, we know that patients with 17p deletion and TP53 mutation tend to have a shorter response time. And so, what I use that for in my practice is I know that those are people that I really have to be sure that we’re following them closely, taking any signs of progression seriously, and always have a back-up plan for what we’re going to do if this treatment doesn’t work.

What Tests Should CLL Patients Insist They Receive?

November 17, 2020/in Chronic Lymphocytic Leukemia, CLL Newly Diagnosed, CLL Programs, CLL Testing, CLL Videos ND, CLL Videos T, INSIST! CLL, Understanding Testing /by GIna Craig

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What Tests Should CLL Patients Insist They Receive? from Patient Empowerment Network on Vimeo.

Which chronic lymphocytic leukemia (CLL) tests are most critical in CLL care? Dr. Jennnifer Woyach details the key tests, what the tests identify, and how they help provide optimal care personalized to each patient.

Dr. Jennifer Woyach is a hematologist-oncologist specializing in chronic lymphocytic leukemia (CLL) at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital & Solove Research Institute. Find out more about this expert here.

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