Tag Archive for: CLL remission

Can Bone Marrow Return to Normal After CLL Treatment?

Can Bone Marrow Return to Normal After CLL Treatment? from Patient Empowerment Network on Vimeo.

Is it possible for chronic lymphocytic leukemia (CLL) patients to achieve normal bone marrow after CLL treatment? Expert Dr. Ryan Jacobs explains MRD-undetectable status and the typical time period to deep CLL remission.

Dr. Ryan Jacobs is a hematologist/oncologist specializing in chronic lymphocytic leukemia from Levine Cancer Institute. Learn more about Dr. Jacobs.

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Transcript:

Lisa Hatfield:

This patient is asking, upon completion of venetoclax (Venclexta) and obinutuzumab (Gazyva) and achieving MRD-undetectable status, how long does it take your bone marrow to achieve improved hemoglobin, hematocrit platelets, white blood cells? And does it always return to normal? And I might add in there just any kind of treatment, does the bone marrow typically return to “normal”? And how long does that take?

Dr. Jacobs:

So the majority of patients treated in the first-line setting and actually in the relapse setting with a combination of venetoclax and obinutuzumab, will have their CLL go into such a deep remission that we cannot detect it in 1 out of 10,000 cancer cells. So that is called MRD-undetectable. Those patients are usually also in complete remission, which means if you look at the bone marrow, you’re not going to see any CLL there. So the majority of patients have their counts normalized while they’re still on the venetoclax. You take it for a year. The complete remission is usually achieved before therapy is completed. And what little, if any CLL is in the bone marrow is not causing a drop in the counts. Now, of course, patients can have the toxicity-reduced counts. And if that’s the case, if it’s a toxicity issue, then it should resolve when you stop treatment. So I would say, usually it does return to normal, if not all…when they’re on therapy, then after therapy. If it’s a relapsed patient that’s seen a lot of therapies though, the bone marrow might never return to normal. 

Lisa Hatfield:

How far out are we from curative therapies for CLL patients with the tougher prognostic indicators?

Dr. Jacobs:

So I think curative is an interesting question, and it can mean different things to different people. But we’ve already shown at the most recent American Society of Hematology meeting, when they looked at the average life expectancy of patients without CLL, since the time that ibrutinib (Imbruvica) got approved and then now CLL patients, the survival curves are overlapping. So as of now, it looks like with our newer treatments that a CLL patient should reasonably expect to live a normal life expectancy. Does that mean cure? Well, if by cure you mean, does the disease go away forever with one treatment? We still don’t think we have that therapy for most patients. But we’ll see as we get longer and longer follow-up with some of these newer agents is there are going to be a proportion of patients that never relapse, that ibrutinib is going to have the longest follow up because it was the first one. I was just looking at a poster at the European Hematology Association meeting where they’ve followed patients seven, eight years out and more than half have still not progressed that got ibrutinib as a first-line therapy. So it’s reasonable to think that maybe some will never progress.


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Can CLL Remission Occur With Rheumatoid Arthritis Drug Treatments?

Can CLL Remission Occur With Rheumatoid Arthritis Drug Treatments? from Patient Empowerment Network on Vimeo.

Is it possible for chronic lymphocytic leukemia (CLL) remission to occur from rheumatoid arthritis treatments? Expert Dr. Ryan Jacobs explains what he’s observed in his CLL patients who also have RA and take RA treatments.

Dr. Ryan Jacobs is a hematologist/oncologist specializing in chronic lymphocytic leukemia from Levine Cancer Institute. Learn more about Dr. Jacobs.

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Transcript:

Lisa Hatfield:

Do any rheumatoid arthritis medications help prevent CLL from returning after treatment with FCR?

Dr. Jacobs:  

I do have a fair number of patients that have rheumatologic conditions and some with rheumatoid arthritis. There are some approvals there, and I in no way pretend to be an expert in rheumatoid conditions. But I do know that there happens to be some agents that are monoclonal antibodies directed against CD20 used to treat some rheumatoid conditions. So I do have some patients that are on drugs like rituximab (Rituxan) to suppress their rheumatoid condition and help prevent recurrences.

And then kind of two birds, one stone also are keeping their CLL in a clinically asymptomatic remission, I’m sure I would say, or stable disease. And it comes with the known risk for long-term antibodies, that there are some increased infections there that was particularly concerned during COVID, the worst parts of COVID. But yeah, so there are some potential treatments like that.


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Emerging CLL Research | Understanding the CAPTIVATE and MAJIC Studies

Emerging CLL Research | Understanding the CAPTIVATE and MAJIC Studies from Patient Empowerment Network on Vimeo.

What’s the latest in chronic lymphocytic leukemia (CLL) research? Expert Dr. Ryan Jacobs shares updates about the CAPTIVATE study, MAJIC study, and potential treatment breakthroughs.

Dr. Ryan Jacobs is a hematologist/oncologist specializing in Chronic Lymphocytic Leukemia from Levine Cancer Institute. Learn more about Dr. Jacobs.

Download Resource Guide   |  Descargar Guía en Español

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Transcript:

Lisa Hatfield:

I did a little research last night before I talked with you, and it sounds like that is something that the CAPTIVATE trial is investigating. A patient asked about that, what that trial is. And it’s music to my ears as a cancer patient to hear something like “fixed duration”, it’s also investigating a fixed duration so patients and have maybe a bit of a medication vacation. So can you speak to that trial a little bit and explain what it is a little bit on how that might benefit patients with CLL?

Dr. Ryan Jacobs: 

Yeah. So one of the best elements of treating with venetoclax (Venclexta) is that it produces a deep level of remission in many patients. In fact, when given with the monoclonal antibody obinutuzumab (Gazyva), to CLL patients receiving that treatment as a first line of therapy for their CLL, about three-quarters of CLL patients will get to so deep of a remission that we call them minimal residual disease negative.

Lisa Hatfield: 

And that’s a blood test or a bone marrow test, but more easily done as a blood test, where we can look to a sensitivity of one in 10,000 white cells and determine if there’s any CLL in those 10,000 cells. We can actually go deeper than that, but we say, we CLL patients are negative if they’re less than one in 10,000. And so 75 percent of patients will get to that depth of remission just with obinutuzumab for six months along with venetoclax for a year.

Dr. Ryan Jacobs:

So when researchers saw that, they recognized that we could probably stop treatment in those patients getting venetoclax because venetoclax yields these deep responses. And then the next kind of thought was, well, could we give a BTK inhibitor with venetoclax, but also over a defined treatment timeline and maybe get some of the remarkable benefits of treating with a BTK inhibitor but not get stuck being on therapy for years and years.

So the CAPTIVATE study was the first really to, in a large Phase II manner, look at that combination in a younger patient population, it was for patients 70 and younger. And it wasn’t in a high risk or anything, it was all comers. But they did have to be 70 and younger and getting treatment as a first-line therapy. So the combination was very effective. As of the last American Society of Hematology meeting in December, four years of data was reported and a large percentage of patients were still free of progression, over 80 percent still free of progression. And that’s three years off therapy at that point.

It was well-tolerated, not many patients had to come off due to toxicity. It was in fact, less than 10 percent had really significant toxicities requiring discontinuation. So it was a well-tolerated effective treatment.

I do have one of those studies to open at my institution, the acalabrutinib-venetoclax combination,  it’s called the MAJIC trial, and it is a large Phase III study that if it’s successful, I think would lead to the approval of giving those two drugs together. But then the extra credit question is, who should get the combination and who should get the drugs separately? And we don’t have an answer for that right now, and that’s a long topic of debate among CLL specialists. 

Lisa Hatfield:

Great. Well, thank you. So for that trial you spoke of that you’re conducting right now, is that… Is it only relapsed patients who are eligible for that? Or is that for front-line therapy.

Dr. Ryan Jacobs:

No, this is a first-line therapy that the MAJIC study is.

Lisa Hatfield: 

Oh good. That’s promising for patients too.

Dr. Ryan Jacobs:

And it has a really good comparator arm, so that won’t be a problem that the standard arm on that study is venetoclax (Venclexta) plus obinutuzumab, so it’s comparing against one of our best treatments, and so we really will get the answer of does it look better to use the BTK with the Bcl-2? Or is it not really that much better than just giving a venetoclax with obinutuzumab? And then the one obvious element that I didn’t mention that would be nice for most patients in addition to being efficacious and well-tolerated is if you could get an all-oral combination. Of course, venetoclax with obinutuzumab, you’re still getting quite a few infusions with the obinutuzumab over the first six months. So that’s a lot of time in the infusion center that you could avoid with just the combination of two oral targeted agents. So that would be a breakthrough for patients too, I think. 


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How Are CLL Patients Monitored After a Clinical Trial Concludes?

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

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

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

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Transcript:

Laura Beth:

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

Dr. Choi:

Oh, good question. Yeah.  

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

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

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

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

What Does Minimal Residual Disease (MRD) Mean for CLL Patients?

What Does Minimal Residual Disease (MRD) Mean for CLL Patients? from Patient Empowerment Network on Vimeo.

What do chronic lymphocytic leukemia (CLL) patients need to know about minimal residual disease (MRD)? Dr. Seema Bhat explains what it is, how it’s checked, and what it means for patients.

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:  

Here’s another question from Anna. She asks, “What is MRD, and does that mean that the disease is cured?” 

Dr. Bhat:

So, MRD is minimal residual disease, and in CLL is defined as the number of leukemic cells that can be detected in the blood or bone marrow following treatment, meaning how many cancer cells are remaining after treatment? This can be checked by a couple of tests. Most commonly, we use flow cytometry. Undetectable MRD is currently defined as the presence of less than one cell – one CLL cell in 10,000 white cells. 

It’s emerging as an endpoint in a number of clinical trials, and presence of no MRD, also called, “MRD-negative status,” although not considered a cure, predicts better outcomes with longer remission. This is being done in combination treatment, and although it’s part of clinical trials currently, with more data available, we may start using this in clinical practice in the next coming years. 

Chronic Lymphocytic Leukemia: Fran’s Clinical Trial Profile

Chronic Lymphocytic Leukemia: Fran’s Clinical Trial Profile from Patient Empowerment Network on Vimeo.

Chronic lymphocytic leukemia (CLL) patient Fran was diagnosed over 20 years ago and has traveled long distances for care. Watch as she shares her CLL journey and the benefits that she’s experienced from seeking out CLL specialists and clinical trials.

“I just think that clinical trials play such an important role in the future…we’ve come such a distance in my 20 years that we would have never come had we not had people that came before me in clinical trials.”

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Transcript:

Fran:

Hi, my name is Fran, and I am 80 years young, just celebrated my birthday. And I have had CLL for 22 years. So, I developed CLL while I was still working as a nurse and as a diabetic specialist within a hospital setting. I was diagnosed as many are, by a simple blood test, having no symptoms. It was really done as part of my military requirement.

And I continued to work and continue my military career. I was a single parent, I am/was a single parent at that time, and I was raising three girls, so I had a busy life, and this was just a sideline as far as my health was concerned. I was in good health, but as the years went on, after two-and-a-half years, my count started to rise again, no symptoms. And the local oncologist that I was seeing decided that it was time for me to begin my first treatment, which was a very simple treatment again, as far as I was concerned, because it was an oral medication that I had no side effects whatsoever from, and it was easy to take once a day, and I did get some improvement in my blood work, of course. It did not put me in remission, but it brought down my numbers a little bit, and I was able to go sort of morally along for another two years when then it became evident again, not because of how I felt, but because of my numbers that I needed additional treatment. This treatment was a little bit more complicated because it was FCR, and that’s chemotherapy intravenous.

But I did say myself, “You need to start paying more attention to this disease,” and I went…I did go for a consultation at a university, about two hours from my home, and the physician was pretty direct with me and saying, “You need to start to pay more attention, get more information, have more testing done regarding the type of CLL you have,” at that point, it was the first time I had heard mutated, unmutated, which I know sounds probably a little crazy with my medical background. But again, I was able to put it in the rear-view mirror, the disease because I felt so well, and/or maybe it was denial.

I was able to come out of retirement and start to teach nursing part-time and work some other jobs. I got married. Life was good, I mean it was even better than good, and my pattern has been that I would get the treatment, get my CLL under control for about three to three-and-a-half years, that was about the time that I started, the numbers started to increase. And so my local oncologist here in Maryland said, “Well, we really need to be looking for something different,” and it was at that time when iguratimod (IGU) had just come out of clinical trials and been approved, so I was in this area, at least one of the first people in their practice to go on iguratimod.

Even though it’s not comfortable geographically, but to begin to look for a specialist and…so three years into iguratimod, I did that. I went to a university hospital setting, about three hours from my home and had way more thorough work-up, but more a work-up that included more tests that were able to give a clearer picture of my CLL, where it was at that point. And this group of doctors at this university setting said, Well, you were on track to maybe another year, and iguratimod to the end of the line as far as treatment for you, and you probably need to be looking at perhaps venetoclax (Venclexta) as your next option.

And I discussed actually with one of the local oncologists about going to see a specialist, and he encouraged me, he did not discourage me, he said, “We’d like to continue, we can play a role here, but we understand where you’re coming from.”

I am so glad that I made the decision, I did, because there is no doubt that this decision at the end of the iguratimod journey for me. I was going to be faced with another crossroads of where do I go from here as far as treatment, and I am quite sure had I not made the decision to go to a research university setting with a specialist that really is heavy into research.

I’m not sure that I would have…I would have ended up on a clinical trial, I’m not sure…I could have navigated all that myself, even with my medical background. Sure, enough the iguratimod did come to an end. And as I did, I was truly, really ready for venetoclax and a physician specialist, CLL specialist that had been at the university setting that I went to, as I mentioned, for my care, he had left that university and moved on a little further away from where I live, I contacted him just for an opinion, and he said, “Well, why don’t you come to see me?” I was in Florida at the time, and so I said, “Okay,” I would. And I did. And he broached the clinical trial.

The benefits definitely outweigh the risks for me. I didn’t realize that I was one of the first 10 or 12 people to take this drug, but I don’t think it would have made any difference because I knew that I had faith, first of all, in my physician and his knowledge, I had faith in the drug as they explained it to me, it was a new way of addressing mutations, and I just felt that this was a good pathway to be on, and that the risks, I felt would be handled by my physician and I would be watching for them, so…I do feel in my case, it was definitely worth the risk. I would say though, that people should really think and read and get as much information as they can about the specific trial that they’re considering, but know that there are just some questions, especially early on, that can’t be answered because they don’t know the answers.

I believe wholeheartedly in trials, and I would say that you have to deal with the, I think the emotion and the fear, the trepidation, this is something new, and try to work through that and concentrate on the positive. I just think that clinical trials play just such an important role in the future that you know of all of medicine, but particularly CLL we’ve come such a distance in my 20 years that we would have never come had we not had people that came before me, in clinical trials. On the other hand, I think you really do need to think about not only the immediacy, but the intermediate and the long range. What do I do if this happens or that happens? That I have to think of this.

This is part of my life now. This is something I have to commit to.

So it’s given me years with my family, with my girls, with my grandchildren, I’m getting to see kids off to college, into high school, Bob and I, my husband have had years that I never thought that I would have.

How to Make Confident and Informed CLL Treatment Decisions

How to Make Confident and Informed CLL Treatment Decisions from Patient Empowerment Network on Vimeo.

How can you engage effectively in your CLL care? Collaborating with your doctor and playing an active role in your care can lead to improved outcomes. This animated video reviews essential steps and important considerations for making informed and confident CLL treatment decisions.

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What Are the Goals of CLL Treatment?

Transcript:

Elena:

Hi, I’m Elena and this is my husband, Bill.

Elena:

Several years ago, I was diagnosed with CLL, which stands for chronic lymphocytic leukemia. CLL is a blood cancer that starts in the bone marrow. It’s the most common type of adult leukemia.

When I was first diagnosed, I wasn’t treated right away. It was confusing at the time, but my CLL doctor, Dr. Singh, told me that most people with CLL don’t need to be treated immediately.

Here’s Dr. Singh, he can explain it further.

Dr. Singh:

Hi! I’m Dr. Singh, and I’m a hematologist specializing in the care and treatment of people with CLL.

At first, we approached Elena’s CLL with “watch and wait” or active surveillance. Through physical exams, blood work and frequent communication, we monitored how her CLL was progressing over time.

Elena:

I was in watch and wait for about a year—then, I begin to have symptoms that interfered with my daily life. I had drenching night sweats and I felt so exhausted.

Dr. Singh:

Right! An increase in symptoms is often an indicator that it’s time to treat a patient’s CLL. Elena’s fatigue and night sweats are common symptoms. Other symptoms can include enlarged lymph nodes or spleen, fever, unintentional weight loss and frequent infections.

In addition to an increase in symptoms, signs that it might be time to treat can include anemia or low platelet counts.

Elena:

So, once Dr. Singh let me know it was time to treat my CLL, he walked me and Bill through the goals of treatment.

And by that, I mean we discussed balancing my lifestyle with finding an effective treatment for my CLL.

Dr. Singh:

Elena let me know that she’s very social and enjoys riding her bike – we wanted to make sure she could continue doing the activities she loves.

The clinical goals of CLL treatment are to slow, stop or eradicate the cancer. I spoke with Elena and Bill about finding an approach that may get her CLL under control while preserving her quality of life.

Elena also had essential testing, including biomarker testing, which we took into consideration along with her treatment goals. We reviewed each potential approach to make sure we found the best, most personalized treatment option for HER CLL.

We discussed the effectiveness of the treatment option, and the likelihood of a recurrence a. And we reviewed what our next steps would be if the treatment plan needed to be adjusted.

Bill:

And I wanted to make sure Elena was able to continue feeling her best, so I asked about potential side effects for each therapy and how it could impact our lifestyle.

Dr. Singh:

Exactly! We discussed how each treatment option could affect Bill and Elena’s daily life. You and your doctor may also consider:

  • The financial impact of a treatment plan
  • Your age and overall health
  • The stage of your disease at the time of treatment
  • And Biomarker test results

Elena:

In addition to asking questions, Bill took notes during our appointments, since it was often hard for me to absorb everything at once.

Bill:

We also made sure to talk about the appointment on our way home, while the information was fresh on our minds. And we did our part by researching CLL and bringing a list of questions to each appointment.

I found an office visit planner on the Patient Empowerment Network website that helped me organize my health info and questions.

Dr. Singh:

As you can see, Bill and Elena were actively engaged in each care decision. It’s vital that patients feel empowered to speak up. If you can, bring a friend or loved one along to your appointment.

And, if you are able, it’s a good idea to seek a second opinion or a consultation with a CLL specialist to help you feel confident in your care decisions.

Elena:

Dr. Singh made Bill and I feel included in the decision-making process, as if it were a collaboration.

Dr. Singh:

That’s right. This is a partnership. So, what steps can you take to be more engaged in your CLL care?

  • Understand and articulate the goals of your CLL treatment plan.
  • Learn about your options and weigh the pros and cons of each approach.
  • Bring a friend or loved one to your appointments.
  • Ask about essential testing and how it may impact your treatment options.
  • Consider a second opinion or a consult with a CLL specialist.

Bill:

That’s great advice, Dr. Singh. To learn more, visit powerfulpatients.org/CLL to access a library of tools.

Elena:

Thanks for joining us.

What Are the Goals of CLL Treatment?

What Are the Goals of CLL Treatment? from Patient Empowerment Network on Vimeo.

What are some of the goals of chronic lymphocytic leukemia (CLL) treatment? Dr. Matthew Davids outlines some different treatment goals and how the goals are impacted by a patient’s age and other considerations.

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:

With CLL, what are the goals of treatment?

Dr. Davids:

I like to say to patients, “The goals are to make you live longer and live better.” You want to obviously have treatments that prolong life, but you also want to have treatments that are helping with symptoms, and giving patients more energy, and making them feel better, and protecting them from some of the risks of the disease. And so, I think the goals do vary a bit based on the stage of life that patients are at.

I see a lot of patients in their 70s and 80s, and in those patient’s symptom control, having the disease be in a good remission, allowing them to live their life is a good goal. I sometimes see patients in their 40s and 50s, and some of those patients want to be a bit more aggressive and try to do a strategy that will get them a very long-term remission, and even potentially explore potentially curative strategies.

If I have a higher-risk patient with deletion 17p who’s young and fit, and they’ve already had some of the novel treatments, that’s where we start thinking about clinical trials of some of the cellular therapies like CAR-T cells that people may have heard of where you use the T cells from the patient to try to use that as a therapy to kill off the disease. Or even a bone marrow transplant is something that we have used historically in CLL. We don’t use it as often now, but for younger patients with high-risk disease it’s still a consideration to try to achieve a cure of the CLL even though the risks of that are significant.