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Chronic Lymphocytic Leukemia Archives
Chronic lymphocytic leukemia (CLL) is a typically slow-growing cancer which begins in lymphocytes in the bone marrow and extends into the blood. It can also spread to lymph nodes and organs such as the liver and spleen.
CLL develops when too many abnormal lymphocytes grow, crowding out normal blood cells and making it difficult for the body to fight infection.
More resources for Chronic Lymphocytic Leukemia (CLL) from Patient Empowerment Network.
When it comes to cancer treatment you or a loved one may be considering participating in a clinical trial as a treatment option. Clinical trials are designed to evaluate the safety and effectiveness of a treatment. They may involve researchers administering drugs, taking blood or tissue samples, or checking the progress of patients as they take a treatment according to a study’s protocol.
Learning about clinical trials can be a steep learning curve – not least because the process comes with a lot of new terms, acronyms and jargon. To help you, I’ve put together this list of the most common terms you will find when you are researching clinical trial information. This is not an exhaustive list but it is a helpful starting point. At the end of this article you will see links to find more information.
Adverse Effects (AE)
Also called Adverse Events, or Adverse Drug Reaction, AEs are any harmful event experienced by a person while they are having a drug or any other treatment or intervention. In clinical trials, researchers must always report adverse events, regardless of whether or not the event is suspected to be related to or caused by the drug, treatment or intervention.
Subsection of people within a study who have a particular intervention.
Bias is an error that distorts the objectivity of a study. It can arise if a researcher doesn’t adhere to rigorous standards in designing the study, selecting the subjects, administering the treatments, analysing the data, or reporting and interpreting the study results. It can also result from circumstances beyond a researcher’s control, as when there is an uneven distribution of some characteristic between groups as a result of randomization.
Blinding is a method of controlling for bias in a study by ensuring that those involved are unable to tell if they are in an intervention or control group so they cannot influence the results. In a single-blind study, patients do not know whether they are receiving the active drug or a placebo. In a double-blind study, neither the patients nor the persons administering the treatments know which patients are receiving the active drug. In a triple-blind study, the patients, clinicians/researchers and the persons evaluating the results do not know which treatment patients had. Whenever blinding is used, there will always be a method in which the treatment can be unblinded in the event that information is required for safety.
When a treatment for a specific medical condition already exists, it would be unethical to do a randomized controlled trial that would require some participants to be given an ineffective substitute. In this case, new treatments are tested against the best existing treatment, (i.e. a comparator). The comparator can also be no intervention (for example, best supportive care).
A trial is considered completed when trial participants are no longer being examined or treated (i.e. no longer in follow-up); the database has been ‘locked’ and records have been archived.
A group of people in a study who do not have the intervention or test being studied. Instead, they may have the standard intervention (sometimes called ‘usual care’) or a dummy intervention (placebo). The results for the control group are compared with those for a group having the intervention being tested. The aim is to check for any differences. The people in the control group should be as similar as possible to those in the intervention group, to make it as easy as possible to detect any effects due to the intervention.
How beneficial a treatment is under ideal conditions (for example, in a laboratory), compared with doing nothing or opting for another type of care. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed.
Eligibility Criteria/ Inclusion and Exclusion Criteria
Eligibility criteria ensures patients enrolling in a clinical trial share similar characteristics (e.g. gender, age, medications, disease type and status) so that the results of the study are more likely due to the treatment received rather than other factors.
Observation over a period of time of participants enrolled in a trial to observe changes in health status.
A process (by means of a written informed consent form) by which a participant voluntarily agrees to take part in a trial, having been informed of the possible benefits, risks and side effects associated with participating in the study.
The treatment (e.g., a drug, surgical procedure, or diagnostic test) being researched. The intervention group consists of the study participants that have been randomly assigned to receive the treatment.
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator (PI).
A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.
Number needed to treat (NNT)
The average number of patients who need to receive the treatment or other intervention for one of them to get the positive outcome in the time specified.
The impact that a test, treatment, or other intervention has on a person, group or population.
Phase I, II, III and IV Studies
Once the safety of a new drug has been demonstrated in tests on animals, it goes through a multi-phase testing process to determine its safety and efficacy in treating human patients. If a drug shows success in one phase, the evaluation moves to the next phase
- Phase 1 tests a drug on a very small number of healthy volunteers to establish overall safety, identify side effects, and determine the dose levels that are safe and tolerable for humans.
- Phase II trials test a drug on a small number of people who have the condition the drug is designed to treat. These trials are done to establish what dose range is most effective, and to observe any safety concerns that might arise.
- Phase III trials test a drug on a large number of people who have the condition the drug is designed to treat. Successful completion of Phase III is the point where the drug is considered ready to be marketed.
- Phase IV trials can investigate uses of the drug for other conditions, on a broader patient base or for longer term use.
A fake (or dummy) treatment given to patients in the control group of a clinical trial. Placebos are indistinguishable from the actual treatment and used so that the subjects in the control group are unable to tell who is receiving the active drug or treatment. Using placebos prevents bias in judging the effects of the medical intervention being tested.
A group of people with a common link, such as the same medical condition or living in the same area or sharing the same characteristics. The population for a clinical trial is all the people the test or treatment is designed to help.
A plan or set of steps that defines how something will be done. Before carrying out a research study, for example, the research protocol sets out what question is to be answered and how information will be collected and analysed.
Randomized Controlled Trial (RCT)
A study in which a number of similar people are randomly assigned to 2 (or more) groups to test a specific drug, treatment or other intervention. One group has the intervention being tested; the other (the comparison or control group) has an alternative intervention, a placebo, or no intervention at all. Participants are assigned to different groups without taking any similarities or differences between them into account. For example, it could involve using a computer-generated random sequence. RCTs are considered the most unbiased way of assessing the outcome of an intervention because each individual has the same chance of having the intervention.
The ability to get the same or similar result each time a study is repeated with a different population or group.
People in a study recruited from part of the study’s target population. If they are recruited in an unbiased way, the results from the sample can be generalised to the target population as a whole.
In clinical trials, the people selected to take part are called subjects. The term applies to both those participants receiving the treatment being investigated and to those receiving a placebo or alternate treatment.
The location where trial-related activities are conducted.
A Stanford Medicine X e-Patient scholar, Marie Ennis O’Connor is an internationally recognized keynote speaker, writer, and consultant on global trends in patient engagement, digital health and participatory medicine. A board member of the Patient Empowerment Foundation, a network of people, foundations, organizations and medical institutions dedicated to empowering patients worldwide, Marie’s work is informed by her passion for embedding the patient voice at the heart of healthcare values. She writes about the experience of transitioning from breast cancer patient to advocate on her award-winning blog Journeying Beyond Breast Cancer.
Suja JohnkuttyHi there ! I’m Suja Johnkutty, MD a conscientious mom and neurologist . My one simple goal is to provide you honest, practical, simple action steps to experience better relaxation in your life. https://betterrelaxation.com
Hi there ! I’m Suja Johnkutty, MD a conscientious mom and neurologist . My one simple goal is to provide you honest, practical, simple action steps to experience better relaxation in your life.
Dr. Kerry Rogers reviews recent chronic lymphocytic leukemia (CLL) treatment advances and explains how patients may benefit from evolving research.
Dr. Kerry Rogers is a hematologist-oncologist at The James Cancer Hospital and Solove Research Institute. More about Dr. Rogers here.
Excellent. What do you think about the future – how do you feel about the future of CLL treatment? What makes you hopeful?
Oh. Well, I think a couple things. One is for CLL, in many ways, the future is now, and I think it’s only going to get better from here on out.
So, a little less than a year ago, two very large clinical trials were reported that compared our best chemotherapy to oral targeted therapy with an ibrutinib-based regimen for CLL, and the oral targeted therapy was superior in terms of something we call “progression-free survival,” which is how long people were alive without their CLL coming back or causing problems.
So, oral targeted agents, which, in general, not – everyone’s an individual, so until you try a treatment, you don’t know what’s gonna happen, but in general, have fewer side effects than chemotherapy, are better at controlling CLL than chemotherapy, so that’s what I like to put in the category of “the future is now,” and I think it’s only gonna get better. So, we’re improving on our existing oral targeted agents with next-generation drugs that have slightly different side effect profiles.
We are also studying combinations of these drugs, and oral targeted agents, and monoclonal antibodies to try to make treatment shorter, to try to get remissions deeper, to really try to improve the quality of life of people taking these therapies and not just improve how long they live with CLL.
And then, for people that really have the worst of the luck with CLL that have really high-risk findings, that don’t benefit for as long as we’d like from oral targeted therapies, that their CLL comes back after a couple years on those, I think the most exciting thing is really CAR T-cell therapies and those cellular-based therapies that aren’t donor stem cell transplant because I’ve seen people who have really benefited from those who had terrible problems from their CLL before that, and I think that’s gonna improve quality of life for a very specific subset of our CLL patients.
That is still in clinical trials for CLL, but has been in enough of them I can feel very confident that we have an idea about what the side effects are and how well it works. So, that’s really exciting. Can I add just one more thing about this before I…?
So, I saw a consult recently for a person that was recommended to start treatment for CLL. His questions for me were, “Should I start treatment now, and what treatment should I take?” This person had never had a treatment before. So, I agreed with his oncologist, who said that he should start treatment now, and his oncologist had talked about several options, but I think with some of the changes in what we’re recommending for CLL, his oncologist had also wanted him to come see me to get a recommendation too, so it was like, “Oh, that’s great. Why don’t you go see Dr. Rogers at Ohio State and see what you should do?”
And so, one of the things he had discussed with the two oncologists in his office closer to his home were, “Oh, we have these – we have ibrutinib, it’s a really outstanding oral targeted agent, but you’ve gotta take it for a really long time, so why don’t you just take chemotherapy, because I think something better will come along?”
And, I was like, “This something better. Literally, this was demonstrated to be better than the chemotherapy. Something better did come along, and it’s this.” So, ibrutinib is better than chemotherapy. I think the idea of “Why don’t we do a less effective treatment because something better might come along?” is not true anymore. We have something better. And, he actually decided to enroll in a randomized phase 3 trial that’s gonna set the new standard of care in CLL, so he was very excited to get treatment as part of a research study. I think he decided that was actually really important to him, and he really liked what the study was.
But, it was just – it was kind of like, “Maybe something better will come along.” I’m like, “Something did.” So, that’s kind of the nice position that many people with CLL are in now. There’s still a lot of work to be done in CLL, but I just get increasingly hopeful as therapies get easier to take and more effective.
When it comes to CLL symptoms, what’s fact and what’s fiction? Dr. Kerry Rogers reviews chronic lymphocytic leukemia (CLL) symptoms and discredits common myths.
Dr. Kerry Rogers is a hematologist-oncologist at The James Cancer Hospital and Solove Research Institute. More about Dr. Rogers here.
Sure. Let’s talk about symptoms a little bit more. Here are a few things that we’ve heard from CLL patients. Are these fact or fiction? “I shouldn’t travel if I have CLL, since I may get an infection.”’
I think that is fiction. So, I’ve heard this, too, and the way I like to think about it is if you’re expected to live with CLL for a very long time, you had better go out and do the things you want to do. This is not supposed to keep you a prisoner in your house. Now, if you’re in the middle of starting some sort of more intensive treatment for it, or less intensive treatment, but you started last week, that is not a good time to go somewhere where there are no hospitals – in the middle of the Pacific Ocean or to rural Africa. So, you’ve gotta be smart about those things, but you wouldn’t go to rural Africa the week after you had a heart attack, either.
So, I think for people who are doing well, living with CLL, but aren’t needing some sort of – in situation where they need a lot of medical visits and care right now, definitely travel. And then, yes, you can get infections when you travel, but you can get infections in your own neighborhood, and I don’t think that keeping yourself only in your neighborhood or where you live is really gonna help you live any better.
You do have to be kind of smart about it. So, if you’re gonna go somewhere where there’s malaria, go to a travel clinic. Make sure that you take the advice of the travel clinic. If you’re going to Houston, you probably don’t need to do anything special. If you’re going to Central America, then you might wanna go to a travel clinic. And, as you know, most people with CLL are instructed to avoid live vaccines, so you have to tell the travel clinic, “I’m going X place. What are the recommendations? I’m not supposed to get live vaccines.” Sometimes, they can recommend low doses of antibiotics to avoid this. They have practical ways to avoid it – for ticks, if you tuck your pants into your socks.
So, being cautious and taking care not to get infections is good advice, but I don’t think it really helps people to limit their travel. Does that make sense? If someone got a stem cell transplant or something, that’s a different category. I’m talking about most people with CLL.
Sure. Well, you mentioned the problem with live vaccines and patients with CLL. Should patients with CLL get a flu shot or vaccines? Because we hear from some patients – they say they shouldn’t.
Yeah. So, because CLL is a cancer of the immune system cells – B lymphocytes – it makes the rest of the immune system function differently than in healthy individuals. So, the benefit that people get from vaccines if they have CLL is actually less, so the – if you get a flu shot, it doesn’t decrease your risk of getting the flu the same way it would for a healthy adult.
However, it’s still a good idea to do because people with CLL live at a higher risk of infection, and the way I view it is you should take every opportunity to decrease your risk for infection because influenza is curable, and if you can decrease your risk even a little bit, I would do it. Now, live vaccines are a bit of a debate because people who are immunocompromised don’t get them. So, live vaccines are a live virus similar to the on that you’re being vaccinated against.
So, examples of live vaccine are the oral typhoid vaccine, the MMR vaccine – I know we’re having measles outbreaks in some parts of the country, so MMR is kind of off the table. There is an intranasal flu vaccine that’s live. It’s very hard to get these days and uncommon to be offered. So, I recommend people get all the vaccines they’re due as long as they’re killed vaccines.
There is now a new shingles vaccine called Shingrix, which is a killed vaccine. I’ve had many patients get that. We’re not sure how well it works in CLL; probably not as well as in healthy adults, but it is safe, so if you get your hands on it – it’s been on shortage – there’s no reason not to get these things. I do think for people that have had really severe vaccine reactions that’s always an individual conversation with your doctor.
Yeah, it sounds like it. How about this one? “I’m not experiencing symptoms, so I don’t need treatment.”
That may or may not be true. So, in some cases, especially if people are in monitoring or observation for their CLL, the goal is to start treatment before you get horribly sick, right?
So, in some cases, you’ll see that the changes in the blood really predict that someone’s going to start to be really sick from CLL in the next few months. You might see their platelet count is going down, or their hemoglobin is going down a lot, and so, there’s kind of a level – so, a platelet of 100 and hemoglobin of 10-11 where you think about treatment. It’s not like, “Oh, you hit this level, you need to do treatment tomorrow,” but it’s time to plan a treatment.
Also, that is the one group of CLL patients where a bone marrow biopsy is really needed to make sure that the decrease in blood counts is CLL and not something else. Most of those people feel fine, but if your platelet count is headed down, it’s probably best to start treatment before your platelet count is below 10 and you start having bleeding symptoms. So, there are some people who are recommended to take treatment for CLL because their doctor has noticed that they’re gonna be at risk for developing problems or symptoms that might make them feel much less well.
And so, you wanna start the treatment when you’re still feeling good and before you’re having a lot of bleeding and issues. However, the majority of people who don’t have symptoms don’t need treatment for it. Quite a while ago, they did randomize people with intermediate- or high-risk CLL to either chemotherapy at diagnosis or delayed until they had one of those treatment indications I’ve been talking about, and treating it with chemotherapy just because you’ve diagnosed it did not help people live longer or better. So, if people are not having symptoms and their doctor doesn’t notice a problem, there’s no reason to treat it.
We talked a little bit how diet and exercise can help with symptoms, but can they control symptoms? Tricky question.
I’m not sure. I think that’s really individual. The thing I get asked all the time is, “What diet do I go on to make my CLL go away, or so I never need treatment?” And, there are no evidence-based diets to make your CLL go away. The coffee enema thing doesn’t work. The no-sugar thing – I’m not sure that works.
I do tell my patients to try to eat and behave as if they’re gonna be around a long time because people with CLL usually expect to live many, many years, and heart disease is still killing people in this country, so you can’t stop managing your diabetes, you can’t start eating hamburgers when you have horrible heart disease, so I think you still have to follow a regular, healthy adult diet.
Most people feel better if they eat fruits and vegetables and try to eat a well-balanced adult diet, so I think that helps pretty much everyone, even healthy adults, but I don’t have any specific diet to control CLL symptoms, although I did have one guy that said ever since he’s been eating white toast every morning, all his symptoms are much better. So, if you find something that works for you, it doesn’t matter what it is. If it’s working out for you, you should do it.
From fatigue to swollen lymph nodes, Dr. Kerry Rogers discusses her approach to managing common chronic lymphocytic leukemia (CLL) symptoms.
Dr. Kerry Rogers is a hematologist-oncologist at The James Cancer Hospital and Solove Research Institute. More about Dr. Rogers here.
Dr. Rogers, we’ve talked a little bit about symptoms – fatigue, night sweats, swollen lymph nodes. How do you manage the symptoms of CLL?
That’s a good question. So, if people have enough symptoms from CLL that’s really impacting their life significantly, then I suggest they take a CLL treatment.
So, if people have big lymph nodes that are interfering with what they’re doing – like I said, that nice man that was too fatigued to get his mail off his porch – that’s a reason to do a CLL therapy, treat the CLL, and make those symptoms go away. The really difficult ones are when you’re not sure if someone’s fatigue is related to CLL.
So, there’s many people I take care of that are living with chronic levels of fatigue that are not enough to impair their daily activities much, and you’re not sure what it could be related to, so one thing I like to do for things that aren’t clearly severe CLL symptoms is try to figure out what else could be causing it. So, I know myself and many other physicians I work with closely that treat CLL – we think we might diagnose more people with sleep apnea than fatigue related to CLL, and getting your sleep apnea treated is very important. So, it’s always important to do a very thorough look to make sure that these symptoms are from CLL.
And then, in terms of milder fatigue, treating CLL won’t always make that better because people usually live with some chronic side effects from the treatment, and it’s really hard to improve on feeling really good. So, if people have some mild fatigue but feel pretty good in general, it can really only make that worse at some point. And, I find that people themselves find ways to manage. Some people who might be in the actually elderly category like to nap, especially if they can and they’re retired.
Younger people actually shockingly sometimes find moderate exercise helpful. And, I know a lot of people find moderate exercise helpful for other forms of fatigue. So, for people living with mild levels of fatigue, that is definitely – people have those strategies to exercise. A couple people really improved their nutrition and found it helpful. So, sleeping better, focusing on maximizing benefit from things you can do, is good.
In terms of night sweats that people get sometimes that aren’t too severe, usually, they find ways to manage with fans or things like that in the bedroom.
These sound like important quality-of-life conversations with your physician.
Definitely. And, I think any time people have symptoms, it’s always good to talk to definitely your hematologist, especially if you have CLL and you don’t know if it’s CLL-related or it could be, and then, also, your primary care doctor or your general doctor, because sometimes, they’re really good at thinking of what else could be contributing, and occasionally, it’s a back-and-forth before you really determine what’s causing this and if it’s CLL-related, but either way, feeling better is really important.
What causes chronic lymphocytic leukemia (CLL)? Dr. Kerry Rogers shares facts and addresses common misconceptions about the causes of CLL.
Here we go. Dr. Rogers, let’s talk about facts and fiction around CLL. Here’s what we’ve heard from CLL patients. Are these fact or fiction? “Exposure to pesticides caused my CLL.”
So, this is a very difficult one, and I will preface this by saying I’m not actually an expert in environmental exposures. I am more an expert in CLL management. But, there is some evidence that exposure to pesticides, including Roundup, increases the risk for developing non-Hodgkin’s lymphoma, and there’s a class-action lawsuit against Roundup that my patients keep asking me about.
I think it’s really hard to say for any one person whether or not their cancer is caused by pesticide exposure. If it’s someone that sprayed Roundup in their garden a couple times, then no, I wouldn’t think so. If it’s someone that was bathing in it regularly, exposed to it on the farm all the time, then it might have contributed, but there’s usually more than one thing that goes into someone getting CLL, so I would never plant the entire blame for something on one particular exposure, but I do think it’s quite possible that pesticide exposure can increase a person’s risk for developing CLL and non-Hodgkin’s lymphoma.
This is probably applicable just to veterans. “I was exposed to Agent Orange, and it caused my CLL.”
So, the same stuff I said about pesticides applies to Agent Orange, but Agent Orange can be a factor in developing CLL. It is in the VA list of diseases associated with Agent Orange exposure. So, for anyone that was exposed to Agent Orange that developed CLL, I would really encourage them to go to the VA and get their Agent Orange intake interview because they are likely entitled to VA benefits because they have CLL and were exposed to Agent Orange.
Do you hear that often from your patients who were exposed to Agent Orange?
That they’ve gone to the VA? Yes. Actually, I have a couple people that – many of these people get care at the VA, which is also great, but I do take care of a couple of people who have VA benefits due to Agent Orange exposure who have CLL for sure.
I also have a couple people that, despite the fact that they were exposed to Agent Orange, didn’t feel like going to the VA and seeing if they could get benefits, and I think that’s very reasonable, too. Whether or not people wanna do that is an individual decision, but is definitely on the list of Agent Orange exposure-related diseases. And so, the VA could provide care, medications for CLL, and in some cases, other financial benefits, so for anyone who would like, I think contacting the VA if you have CLL and were exposed to Agent Orange is not a bad idea.
How about this one? “CLL is only a disease of the elderly.”
Oh. Well, that one is definitely not true. So, CLL is not really a disease of children. I’ve never seen someone under 18 with it, and of course, the median age of diagnosis is somewhere between 65 and 70, sort of around 65, so that means that there’s a lot of people less than 65 living with CLL.
I’ve seen people as young as 20, I’ve seen some people in their 30s, I see many people in their 40s and 50s, and also, part of this question is what do you consider elderly? I don’t really know that I consider people in their 60s elderly in many cases. So, people in their 90s are usually willing to accept that they’re elderly, but people in their 60s, often, I wouldn’t call them elderly, and I know you draw these age numbers to say you’re a senior citizen, but there’s more things that contribute to the word “elderly.”
So, I guess what I’d say is this is – CLL is definitely not exclusively a disease of the elderly. There are many people in their 40s living with this, and I’ve seen people as young as their 20s, and then, also, you gotta figure out for yourself where you’re gonna draw the line and say “elderly.”
Sure. How about this one? “CLL is genetic, and my children may inherit it.”
So, this is a very difficult question. Instead of saying CLL is genetic, I think what I would say is that CLL is heritable, meaning it can run in families.
And, the rough estimate is that 1 in every 10 people that are living with CLL have someone in their family that will also get CLL, so we know that it does run in families – not in every case, but many cases – and I think at least in terms of people I’ve seen with this, people come and see me, and they either say, “Oh yeah, sure, my cousin, my uncle, my parents, my brother – everybody had CLL.” Or, they’ll say, “Really? Someone else in my family could get this?” So, it becomes pretty clear who’s gonna have it in their family and who’s not, but it does increase the risk of your family members getting CLL.
The interesting part of that is as a CLL community, I think we have not done a very – or, we have not been able to pin down a gene that causes it. So, if you think about breast cancer, colon cancer, you can say, “Oh, someone has a BRCA mutation, the family needs to get tested, we can do something to avoid your kids getting breast cancer.”
But really, with CLL, they’ve done a lot of research looking at family cohorts – and, by “they,” I mean not me specifically, but other CLL researchers have done this – and really have not identified anything that’s saying, “Oh, if you have this gene, you’re gonna get CLL, you’re at risk for CLL,” so, we can’t say it’s genetic and there’s one gene it’s pinned on, although it might be genetic based on a constellation of genes or a gene we haven’t identified. So, I think that’s kind of interesting.
The other thing that I’ll say that’s really important when thinking about whether or not your family could be at risk for CLL is that even people that have very what we call unfavorable or high-risk CLL, with something like deletion 17p, other family members that have CLL end up having a pre-CLL condition called monoclonal B lymphocytosis, or 13q CLL, or 11q CLL, so they have a completely different genetic feature for their CLL, even though you can tell they’re in the family as people with CLL.
So, it’s not that the CLL genetic factors we use to predict how you’re gonna do with it are inherited throughout the family, just the risk for getting CLL. I think that’s important to realize.
The other thing is that unlike breast cancer, where you say, “Oh, this is in your family, you should get breast MRIs, you should consider a prophylactic mastectomy,” there’s not a good screening system for CLL, and since when it’s diagnosed, it’s observed, and there’s no known way that we have to prevent it, it’s not like you have to go and get your entire family tested because we don’t have a genetic test, and a screening is not as beneficial as it is in breast cancer where you can get a surgery to prevent yourself from getting the disease. Does that make sense? Okay.
Thank you. What are some of the things that you hear from your patients that we haven’t mentioned?
About the way they got it.
Oh, the way they got it. Hmm.
I think the most common things I hear from people that we haven’t mentioned are in either the exposure category, to things that aren’t known to cause CLL, or infections, like, “Oh, I had a really bad bout of influenza,” or “I got pneumonia, and then I got CLL.” I don’t know if these – I don’t know if any infections that are demonstrated to cause CLL.
Sometimes, the white count can go up when people have infections in response to that, because they’re still living immune system cells, so if people get diagnosed when they have an infection because they got their blood drawn or because their white count went up because they were sick, but that’s something common I hear. And so, it’s really hard to say, “Your bout of pneumonia isn’t why you got this,” but it is frequently how people get diagnosed with that, so I hear that sometimes.
What are the actual causes of CLL? What do we know?
So, CLL, like most blood cancers is – the way I like to think about it is that your blood cells are one of the most rapidly growing and dividing cells in the body.
You know how over the course of your lifespan, your skin sloughs off, your hair grows, you have to cut it? So, your blood cells divide and turn over within your body, and they’re really quite rapidly dividing, and when cells divide, they replicate their genetic material, and just because it happens so many times over the lifespan, they make mistakes and pick up mutations.
So, many of the mutations they pick up either cause that cell to die, which is fine, or cause your immune system to attack it as abnormal, which is fine. But, in some cases, the mistake or mutation they made when the cells were dividing causes the calls to become broken or mutated in a very specific way that makes them CLL. And, it’s probably not just one mutation; it’s probably a series of them that accumulate to cause CLL.
And so, some of these things are those things we test for in a FISH panel, like 17p is an abnormal genetic change that happened as these cells were dividing over the course of the person’s lifespan, but there’s probably more changes than that that go on, and eventually, the cells become CLL, grow out of control, and have the common features of CLL. So, that’s how I like to think about it.
And then, these questions of “Oh, did pesticides contribute? Did this contribute? Did Agent Orange contribute?” is really just about did those agents cause your cells to break or mutate more, or in a specific way that would make them CLL? So, a lot of things that cause cancers in general, and not just CLL or increased risks for cancers in general, are things that alter, break, or change DNA.
Dr. Kerry Rogers explains chronic lymphocytic leukemia (CLL) staging and how it can impact a patient’s prognosis, treatment options and overall care.
Let’s talk a little bit about how CLL is staged, Dr. Rogers.
So, unlike most cancers, where CLL is staged with CT scans or PET scans, the staging for CLL is actually remarkably simple, and I really like this because it limits the amount of testing you have to do for people, especially the people that might be just monitored for their CLL or observed. You don’t wanna put them through a lot of intensive testing they don’t need. So, the only two things you need to properly stage CLL are a complete blood count and a good physical exam.
So, in the United States, we use something called RAI staging, which is R-A-I staging, and before I launch into what it is, I will just say that even RAI stage 4 CLL is very treatable, and people do well for many years, so this is not the same as when you think about lung cancer or breast cancer staging, where stage 4 is a much worse spot than stage 1. The staging for CLL – all of it is still very treatable.
So, RAI stage 0 is when you only have an increase in lymphocytes, which is the CLL cells in the blood. Stage 1 is when you have increasing lymph nodes in addition to that. Stage 2 is an increased size of the liver or spleen. And then, if someone has anemia from CLL, then it’s stage 3, and stage 4 is if you have low platelets from CLL. So, 3 and 4 are indications that the bone marrow’s not working well due to CLL.
Dr. Rogers, it seems like CLL is a very manageable disease. What are you considering when you’re making a prognosis with a patient?
So, for many people, CLL is a very manageable disease. Like I said, some people have had CLL longer than I’ve been a doctor and have needed no treatment for it. However, there are people with CLL that go on to have a lot of difficulty from it, including not doing well with more than therapy or needing really new, advanced therapies, like something called CAR T-cell therapy.
So, for any individual person, you can never say how it’s gonna turn out for them, but we do use our experience taking care of lots of people with CLL to make an educated guess as to if this person’s gonna be someone that’s gonna expect to need a lot of treatment in their lifetime, or maybe no treatment in their lifetime.
And, the main things we look at in addition to just the staging or are they having symptoms or problems from CLL yet is molecular testing. So, these are genetic tests just on the cancer cells, so they’re not genetic tests that other people in the family get tested for, it’s just changes in the cancer cells, so that can give us a guess as to how long before people need treatment and how well they’ll respond to treatment.
And, I know a lot of people are probably already familiar with this, but there’s a particular chromosome change you can test for called deletion 17p, and that predicts a shorter time to needing treatment, needing more treatments in your lifetime, maybe going on to needing those advanced treatments like CAR T-cell therapy.
It used to be recommended that people with 17p get regular like-donor stem cell transplants, which, in some cases, is still done. And then, on the other end of the spectrum, there’s a chromosome change called deletion 13q, which predicts that in many cases, people don’t need treatment for many years and do very well. So, there’s a panel of chromosome changes that can predict where people are gonna fall on the spectrum.
The other chromosome change that’s become important is something called complex karyotype – and again, this is just in the CLL cells, but the karyotype is the arrangement of the chromosomes and these – the other tests I was talking about are chromosome changes picked up with a test called FISH. This is just looking at all the chromosomes, what they look like, and if there are three unrelated genetic abnormalities are more, it’s something called a complex karyotype, and it predicts people will fall in this category of needing more treatment or having more things to do with their CLL in their lifetime rather than not.
And then, the third thing that is really important is something called – and, this is gonna sound long – but, it’s immunoglobulin heavy chain gene mutational status, and mutations in the immunoglobulin heavy chain gene occur normally as these B cells mature, so people that are mutated have more mature cells that became CLL, and people that are unmutated have less mature cells, and people who are mutated that have more mature cells tend to have fewer problems from CLL in their lifetime, and there’s a few implications for CLL treatment for that category.
So, I kind of take all those things into consideration, and then, the other thing that I think is important to consider is newer molecular testing, but that’s still in development, so I think I’ll just end there for now in what I take into account.
I did want to ask one follow-up. Dr. Rogers, how often do you like to check in with your patients with CLL?
Oh, that’s an excellent question, because I think it really depends on how they’re doing.
So, people that have had a lot of changes in their CLL, like the white counts increasing, healthy blood counts going down, lymph nodes changing – then usually, I see them back more often, so I even see someone maybe six or eight weeks later if they have a lot of changes. And then, generally, people who are having changes in their CLL are taking treatment for CLL; I’ll see them at least every three months.
However, like I said, there are people who have had this CLL for decades with no changes in how their disease is, so those people I’ll see every six months, or even sometimes once a year, especially if it’s been 10 years and nothing has changed with the CLL. Even though I like them and enjoy seeing them, I’m sure they have things they’d like to do rather than coming to see me.
Dr. Kerry Rogers defines chronic lymphocytic leukemia (CLL) and reviews key indicators that could signal it’s time for a patient to begin treatment.
Dr. Rogers, let’s just get a brief overview of CLL and how it progresses.
So, I’m sure everyone already knows that chronic lymphocytic leukemia is a chronic blood cancer of a cell called the B lymphocyte, and with the frequency that people are getting blood tests these days in the United States, the most common way that I see people diagnosed with this at this time is actually just having an increased white blood cell count when they went to get routine blood counts.
So, it seems like the majority of people being diagnosed are diagnosed at a time when they’re not actually having symptoms from the disease, and maybe everyone already knows or not, but the way that’s managed is that the disease is actually just monitored until some sort of what I like to call “problem” from it develops.
So, I’ll go over what the problems are that can come along as the CLL progresses, but it’s important to realize that there’s many people alive and living with CLL doing very well and not having any problems from the disease yet, and I’ve seen a couple people that have had this disease longer than I’ve been a doctor, and one person that almost had this longer than I’ve been alive with no problems from it.
So, developing something from CLL that’s gonna need treatment is not universal. So, as the – for the majority of people, though, CLL – over its natural history – will go on to progress to cause what I like to refer to as “problems” from it. Some people call them “treatment indications.”
So, when problems are developing is about the time you consider treatment before you get really sick from it, and there’s a couple main ways that the CLL can cause problems. One is that the CLL can build up in the places where those cells live, which is the lymph nodes, so people can get really big lymph nodes in their neck, in their groin area, sometimes inside the body, causing problems. And, lots of people have small lymph nodes that aren’t causing problems, and that’s okay, but if they become really big or problematic, then it’s time to do something about them.
The cells can also build up in the bone marrow, so the bone marrow produces all your healthy, normal blood cells that go into the blood and have a lifecycle in the blood. So, if your bone marrow fills up with CLL cells, then you can’t produce the regular, healthy blood cells, and it’s time to do something about the CLL.
Sometimes, the white count can get really high, and that’s not always a reason to do something, but most people do see – over the natural history or course of having CLL – their white blood cell count and lymphocyte count increases, and there’s not actually a firm number where you say, “Boy, you hit X number, it’s time to treat this,” but if the count is increasing rapidly, then usually, you want to treat this before it increases so much that you develop an issue from that. And then, the last category of things that happen with CLL that’s a problem from it are what we call constitutional symptoms.
So, this can be fatigue that’s limiting your activities, like I took care of someone that was too tired to get the mail from his porch due to CLL. He’s doing great now, but that would be a problem. Sometimes drenching night sweats or an extreme weight loss – and, I’m not talking about people that do Atkins diet lose weight, I’m talking about people that are eating everything and losing weight just because of the CLL.
And, the reason this happens that – CLL is a cancer of B lymphocytes, which are immune system cells, so they can release some of the same chemical mediators that your immune system releases for an infection, and that’s what causes some of those symptoms. But, the main things that progress over the course of having CLL are increasing lymph nodes, lowering of your healthy blood counts due to increasing CLL in the bone marrow, the white count can go up rapidly, or people can develop really problematic constitutional symptoms from it.
Introduction to Leukemia
Cancer and neoplastic lesions are affecting our lives every day. Nearly 40% of the world’s population is affected by cancer—irrespective of age, gender, and ethnicity. Equally detrimental to cancer’s physical manifestations are the psychological influences. However, medical advancement and new research are helping to to combat this life-threatening disease.
Of all the cancers of the body, the most treacherous is Leukemia. It is a cancer of blood cells. Humans have three kinds of blood cells: red blood cells, white blood cells, and platelets. Leukemia involves the malignant proliferation of white blood cells (WBC).
Our white blood cells are major components of our body’s defense mechanism. They play a vital role in fighting against diseases, whether bacterial, viral or fungal in nature. They originate within the bone marrow, spleen and lymph nodes.
A person suffering from Leukemia has poor white blood cell functioning. WBCs start to divide abnormally eventually outgrowing the normal number of cells.
Leukemia has 4 types:
- Acute Myelogenous Leukemia (AML)
- Chronic Myelogenous Leukemia (CML)
- Acute Lymphocytic Leukemia (ACL)
- Chronic Lymphocytic Leukemia (CLL)
1. Acute Myelogenous Leukemia (AML)
Acute Myelogenous Leukemia is a heterogeneous clonal disorder. It is characterized by immature myeloid cells and bone marrow failure. It commonly affects children and adults. Studies have suggested the disease arises from recurrent hematopoietic stem cell genetic alterations.
2. Chronic Myelogenous Leukemia (CML)
Chronic Myeloid Leukemia is a myeloproliferative (slow-growing blood cancer) disorder characterized by the existence of a balanced genetic translocation of chromosomes 22 and 9. It mostly affects adults. CML consists of 3 distinct phases: chronic, accelerated, and blast phases.
The history of patients with CML shows 3-5 years of chronic stage proceeding to a fatal blast phase and then progressing to an accelerated phase.
3. Acute Lymphocytic Leukemia (ALL)
Acute Lymphocytic Leukemia is the second most common Leukemia occurring in adults. Like other Leukemias, ALL’s pathophysiology is also based on chromosomal abnormalities and genetic alterations which happen to take place in differentiation and proliferation of lymphoid precursor cells present in the bone marrow and blood. In adults, the precursors of B- lymphocytes are greater in number than the malignant T- lymphocytes.
4. Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic Leukemia is a tumor of CD5+ B cells that characterizes the deposition of tiny, mature lymphocytes in the blood, bone marrow and lymphoid tissues. Apart from the CD5 cells, other genetic alterations are involved in the pathogenesis of Chronic Lymphocytic Leukemia. Stromal cells, T cells and nurse-like cells in the lymph nodes also predominate.
Causes and risk factors for Leukemia
Although the exact cause of Leukemia is unknown, certain risk factors can contribute to making a person susceptible to it. These include radiation, viruses, exposure to benzene, smoking, genetics, and family history.
1. Ionizing radiations
Exposure to ionizing radiation comes from continuous radiation therapy for treating any pre-existing cancer. Prolonged exposure to X-rays is found mostly in people who work as radiologists and are exposed to persistent radiation. Patients who have received chemotherapy sessions for cancers are also prone to Leukemia. Ionizing radiations damage the DNA and result in the defective genetic makeup of stem cells.
The Human T-lymphotropic Virus (HTLV-1) has been shown to have an association with Leukemia.
3. Exposure to benzene
Benzene is a toxic solvent used in cleaning chemicals and some hair dyes. Benzene’s toxic effects on the blood and bone marrow include increasing the risk of Acute Myeloid Leukemia (AML), myelodysplastic syndrome, and other hematological malignancies, such as non-Hodgkin’s lymphoma.
Smoking is not only detrimental for the lungs alone but for the entire body. Although the link between smoking and Leukemia is unclear, studies say it can affect the bone marrow and increase the chances of AML in young adults.
5. Genetic conditions
Chromosomal abnormalities are also responsible for increasing Leukemia susceptibility. Examples include Down syndrome, Klinefelter syndrome, Fanconi anemia, Li-Fraumeni syndrome, Bloom syndrome, Ataxia-telangiectasia, and neurofibromatosis, to name a few.
The most common cause of Leukemia is family history. If any family member has had Leukemia it increases the risk for other blood relatives.
Signs and symptoms of Leukemia
The signs and symptoms of Leukemia vary with different forms. They are generally nonspecific and warrant investigations for proper diagnosis.
Acute Myeloid Leukemia (AML)
The signs and symptoms of AML are:
- Pain in bones and joints
- Pale skin
- Easy bruising and contusions
- Recurrent infections
- Unusual bleeding, epistaxis, bleeding gums
Chronic Myelogenous Leukemia (CML)
The signs and symptoms of CML are:
- Fatigue and muscle weakness
- Shortness of breath
- Increased sweating mostly during the night
- Cachexia (weight loss)
- Abdominal discomfort secondary to spleen enlargement
- Stomach bloating
- Pain in joints and bone
Acute Lymphocytic Leukemia (ALL)
The signs and symptoms of ALL are:
- Joint pain and muscle fatigue
- Frequent infections
- Epistaxis (Nose bleed)
- Lumps felt around the neck, groin and underarms as a result of lymph node swelling.
- Pale skin
- Shortness of breath
Chronic Lymphocytic Leukemia (CLL)
The signs and symptoms of CLL are:
- Nocturnal sweating
- Recurrent infections
- Fatigue and constant tiredness
- Loss of appetite
- Stomach bloating as a result of splenomegaly (enlarged spleen)
- Shortness of breath
- Pea-sized swelling or lumps in groin, neck or armpits.
Diagnosis of Leukemia
Early detection can prevent complications. The earlier the diagnosis the easier treatment is. Medical advancement has made diagnosis easier than ever before. Some of the essentials to reach an accurate and precise diagnosis are enlisted below.
History and examination
A proper and detailed history is the key to an ideal diagnosis. It involves asking relevant questions related to the signs and symptoms that can link to the suspected disease.
Your physician might ask the following questions:
- How long have you been feeling a fever?
- What is the temperature?
- Do you feel a loss of appetite?
- Have you experienced prolonged bleeding after a cut?
- Have you noticed any changes in weight recently?
- When did you notice lumps?
- Are these lumps felt, painful and movable?
- Did you feel the lumps gradually increasing in size?
- Do you face difficulty in breathing?
- Do you feel you sweat a lot while sleeping?
- Are you taking any medications?
- Have any of your family members had any diseases?
- When did you feel the need to visit the physician?
The answer to the above questions can lead to the next step, investigations.
Investigations for Leukemia
Investigations are the major component involved in diagnosis as they make the suspected disease clear to understand. These include blood tests, radiology and biopsy.
1. Blood tests
- Complete Blood Count (CBC)
- White Blood Cell (WBC) differential
- Blood smear
- Tumor markers
- Cerebrospinal fluid (CSF) analysis
- BCR ABL1
- Genetic tests for targeted cancer therapy
- Chromosome analysis
The most commonly used test is the Complete Blood Count (CBC) which shows a clear picture of the abnormal growth of red blood cells, white blood cells and platelets.
The excessive proliferation of the cells in the bone marrow leads to marrow expansion and invasion of the cortex which, in later stages, can be seen by radiographic studies. A simple X-ray can reveal any spot bone changes. In some circumstances, a CT-scan may be needed to extensively study the disease and prognosis.
X-ray findings may include:
- Osteolytic lesions; most commonly seen in Acute Lymphocytic Leukemia seen in small and flat bones, metaphysis of long bones.
- Metaphyseal bands (classical Leukemia lines)
- Bone destruction
- Some pathological fractures
- Radiological lesions, in later cases, are seen in the form of vertebral collapse, osteolysis of bones and avascular osteonecrosis.
3. Bone marrow biopsy
This is the gold standard investigation to diagnose Leukemia. This invasive procedure is done after the suspicion of Leukemia or when the blood test reports point to a Leukemic picture.
The procedure involves the removal of a small sample of bone marrow from the hipbone. A long, thin is the needle is used to extract the bone marrow. Once the sample has been taken it is sent to the laboratory where the histopathologists study the tissue microscopically.
Prior to examining the histopathologist or the lab technician prepares a slide. During the process, the specimen is then cut into thin slices. The sectioned structure is dyed using different dyes. The dye discriminates against the parts of the cells. The section is then placed on a glass slide and then covered with a slip on the top to keep the specimen intact. The slide is now ready to be placed under the microscope.
The samples examined under the microscope are then studied based on the type of cells, how the cells are arranged, whether the cells are normal or abnormal etc.
The microscopic findings may reveal:
- Acute Myeloid Leukemia
Increase in bone marrow cellularity, consisting of granulocytic or monocytic forms a number of erythroid precursors
- Acute Lymphocytic Leukemia
Hypercellular bone marrow with multiple tightly packed lymphoblasts that have undetectable cytoplasm, round irregular shape, divided nuclei, and dispersed chromatin. The bone marrow has B and T lymphoblasts with indistinguishable morphology along with necrosis in some areas.
Treatment for Leukemia
Treating Leukemia challenges all medical practitioners. Its success and failure solely depend on the extent of the disease and how far has it spread within the body.
Following are treatment options that can help fight Leukemia.
Chemotherapy is the use of anticancer drugs to kill or halt the proliferation of cancer cells. Generally, chemotherapy is administered orally or intravenously. In some patients, the chemotherapeutic agent is given intrathecally, i.e., injected into the CSF (cerebrospinal fluid) that bathes the brain and spinal cord. This is done after performing a lumbar puncture and injecting chemotherapeutic drugs, such as methotrexate. The course is usually repeated every three weeks.
Compared to chemotherapy that attacks all the cells of the body, including the healthy ones, radiotherapy is a localized treatment regimen. High ionizing-energy radiation emits to destroy cells that have an increased proliferation rate. Radiotherapy can either be given to cure the disease (therapeutic) or to improve the signs and symptoms encountered during the disease course (palliative).
3. Stem cell or bone marrow transplantation
Transplants are widely used in management and treatment of the disease. Bone marrow is transplanted from a patients’ family member, or another person who bears the same type of bone marrow, into the diseased person. The survival rates vary with different factors but the cost and affordability remain the major concern in this treatment modality.
4. Immune therapy
Immune therapy is another set of treatments that has some promising result in managing Leukemia. The immune therapy works by promoting the immune cells of the body to fight against cancer cells. One of the successful regimens in immune therapy is Gleevec, commonly given in Chronic Myeloid Leukemia. CML patients live a long, symptomless life with the daily oral administration of this drug.
Complications with Leukemia
Though Leukemia is curable, treatments may give rise to certain complications–basically the body’s response to the treatment given. The complications mostly arise from chemo and radiation.
They can include:
- Skin rashes
- Altered taste sensations
- Soreness of the mouth and throat
- Liver dysfunction
- Hair loss
- Fertility problems
- Nausea and vomiting
- Neurological effects
- Impaired sexual activity
Relapse of the disease may also occur after some years.
The prognosis of Leukemia depends on how far has the disease has spread but the medical advancement has brought in new regimens that can now treat Leukemia at any stage. A person suffering from Leukemia and undergoing its treatment should be dealt with love, care, and pampering
How to help prevent Leukemia
Informational campaigns and awareness programs help people learn about the risk factors of Leukemia. Family members of Leukemia patients should undergo blood screenings to see if they have been affected. A good diet can help improve health status. Limiting use of benzene-infused chemicals can also make the disease less susceptible. Ceasing tobacco smoking can also help keep Leukemia at bay.
Dr. Matthew Davids defines the term minimal residual disease (MRD) and explains its role in managing chronic lymphocytic leukemia (CLL).
Dr. Matthew Davids is the Associate Director of the CLL Center at Dana-Farber Cancer Institute. More about this expert.
Dr. Matthew Davids
So, one term that patients often come across when they’re looking online that they might not know exactly what it means is so-called MRD. This stands for minimal residual disease.
And MRD is increasingly becoming an important endpoint in our trials, meaning that it’s a test that we rely on to try to make decisions about treatment in the trials. And we’re hoping that this will be a strategy that we can eventually use in regular clinical practice.
So, what is MRD? Basically, MRD is a way to look, at a very, very molecular level, at tiny, tiny amounts of the disease. And this a feature of the fact that we have very effective treatments for CLL, and so we can give various treatments, whether it’s chemoimmunotherapy or drugs like venetoclax, for example. And then we can look under the microscope in, for example, the bone marrow tissue, and we might not see any CLL cells. So, we might call that a complete remission.
But often, there’s still evidence of molecular disease left behind that we can’t see under the microscope, but we can use very sophisticated biological techniques to actually detect what we call MRD. And we find that, if there is MRD present, that patients don’t tend to have as durable of a remission compared to when MRD is so-called undetectable.
So, it’s a very important term to understand. When patients get to an undetectable MRD state, that’s a very good thing. It means that they’re likely to have a very long response to whatever therapy they had. But you also have to remember that MRD itself has its limits of what it can detect. And so, just being undetectable for MRD does not mean that you’re necessarily cured of the CLL.
And there are patients who have undetectable MRD who later do have a recurrence of the CLL. But it does help us guide the treatment in terms of knowing that patients are in a good remission, that they may be able to stop the treatment that they’re on and enjoy a long response without the need for ongoing treatment.
But eventually, for most CLL patients, the disease will come back. And we can detect that sometimes with this MRD test as well. And that’s an interesting research question ongoing as to whether we should intervene at that point to restart therapy when we first see the MRD test become positive again. And hopefully, that’s something that we’ll continue to learn about as we further explore that question in clinical trials.
You’ve been diagnosed with chronic lymphocytic leukemia (CLL), now what? Dr. Matthew Davids explains key steps to take following a diagnosis.
Dr. Matthew Davids is the Associate Director of the CLL Center at Dana-Farber Cancer Institute. More about this expert.
Dr. Matthew Davids
So, if I were diagnosed with CLL today, we’ve discussed some of the resources that are available in terms of educating one’s self about the disease: CLL Society website, other videos on VJHemOnc, things like this. There are other websites that give more basic information about the disease, for example, Lymphoma Research Foundation, American Cancer Society, American Society of Clinical Oncology.
So, personally, I would want to know a lot about the disease. And I would probably first turn to these particular resources, which I think can be very helpful.
I would certainly partner with a local oncologist hematologist who can help guide the management. But one thing that you should remember is that most general practitioners for oncology may only see a few CLL patients a year, and the field has changed quite a bit over the last few years. And it can be hard to stay completely up to date on all of these developments.
So, one thing that I would think would be very helpful for anyone diagnosed with CLL is that, if you do have access to a major center that has someone who specializes in CLL or at least in lymphomas, that can be a great resource. And so, I do recommend, if patients can do it, to try to seek out a second opinion from a CLL specialist. And this can be very helpful even if the recommendation is still just observation, that they can help educate about the disease, identify other resources for educational purposes, and just become a part of your team, to have them available down the line.
And I see many patients like this who come for a second opinion at diagnosis. And I kind of tell them, “Go back to your local doctor. Stay on observation. It’s likely you’ll do well for many years on this watch and wait strategy. But at the time when they’re recommending that you need treatment, come back and see me then. It’s easier to get in once I know you.”
And at that point, I can help reassess, 1.) Do I agree that treatment is really needed at that point? Sometimes, it’s actually possible to wait even a bit longer; and then, 2.) What would I recommend for the best treatment option at that time? Could be a clinical trial that might only be available at that center. And I think unless you have a CLL specialist on your team, it’s gonna be hard to know about those available resources.
So, it’s not that you necessarily need to follow exclusively with a CLL specialist. But it’s more to just have them involved, have them know about you. And that way, if you need them down the line, they’ll be available to help support you.
I think in terms of education and self-advocacy, this is a very personal issue. And so, for many of my patients, it’s very important that they are educated about the disease and kind of know the ins and outs of the different clinical trials and so forth.
But it’s also important to remember that that’s not gonna be true for every patient. A lot of my CLL patients are also older patients, and they may not want to know all the details of what’s going on. I think it is important to have someone who’s involved with your care know about these details. Ideally, if it’s not you, it might be a spouse or a partner or a child, for example. A lot of my older patients don’t wanna know all the details about the molecular biology and the clinical trials. But often, it’s their son or daughter who is there with them who wants to know this.
And so, I think it’s helpful often to bring a family member with you to the visits. Because as you can see even from today, there’s a lot of information to learn, and it can be hard to remember everything.
So, having someone else, another set of ears and eyes, someone else can maybe take some notes at the visit and review them with you later, I think can be very, very helpful in terms of your own self-awareness about the disease.
So, in general, I love when patients ask me questions. Sometimes, they are very savvy questions. They are familiar with the literature, and they can kind of really push me to explain my opinions and beliefs about certain treatments. And sometimes, they’re just very basic questions that may be seem silly to the patient but are really not silly questions.
Really, this is a brand-new area for most patients. They have no experience with this when they first start out. So, they should never feel like they’re bothering their oncologist with these questions. I think it’s really important for them to understand the basics of what’s going on. That should really be a minimum for every patient.
And then for patients who wanna know more about some of the details from the research and the clinical trials, I think their doctor should also be able to help explain that to them as well. So, they should never feel like they’re bothering their oncologist with their questions.
Is participating in a clinical trial a last resort or could it be your best treatment option? Dr. Matthew Davids explains the clinical trial process and what’s involved in patient participation.
Dr. Matthew Davids is the Associate Director of the CLL Center at Dana-Farber Cancer Institute. More about this expert.
Dr. Matthew Davids
My patients often ask me about clinical trials and whether I think that would be a good fit for them. I think there is, in some cases, a bit of a misconception that clinical trials are a last resort for our patients. And we do have some clinical trials that are exploring brand new mechanisms of a drug that have never been used before.
And in that scenario, I would only recommend a trial like that for a patient who has already exhausted all of the standard options.
But I think that, in my opinion, clinical trials should really be the first best choice for most patients. Because we have many trials in CLL that are using the drugs that are already approved, so we know that they’re gonna be effective. And now, we’re putting them together for the first time in new combinations and in new creative ways that will help to advance the field. And most of the trials we have in CLL are not randomized, placebo-controlled. So, patients know what they’re getting. They’re gonna be getting an effective therapy.
And this is a way that they can really get access to cutting-edge care. I would say when you’re a part of a clinical trial, you have a lot of other eyes watching you. In addition to your oncologist and the infusion nurses, for example, you also have research coordinators, research study nurses. Some centers have additional scheduling staff that helps with the clinical trials. So, it’s really a way to get excellent quality clinical care, often getting access to cutting edge treatments.
And so, here at Dana Farber, for example, we try to have a clinical trial option available for patients at every stage of the disease, so that we have trial options for patients who have never had treatment for their CLL, trial options for patients who have maybe only had one or two prior treatments, and then some of those other more experimental clinical trials for patients maybe who have exhausted some of the other options that are available by the FDA-approved therapies.
So, I’m really a huge advocate for clinical trials. I think that’s how we’ll continue to improve the treatment options for our patients with CLL.