DLBCL Treatments and Clinical Trials Archives - Page 4 of 7

Are Clinical Trials Safe?

Are Clinical Trials Safe? from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack explains the safety protocols in place for clinical trials, including how data is reported and protected. Patient advocate Sujata Dutta goes on to share her experience in a clinical trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

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Is a Clinical Trial a Last-Resort Option?

A Patient Shares Her Clinical Trial Experience

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

Transcript:

Katherine Banwell:

Some patients feel that clinical trials aren’t safe, is that the case, Dr. Pollack?

Dr. Seth Pollack:

No. I mean, we go through, as I was saying before, these clinical trials are extensively vetted. So, the safety is, of course, one of the things that we look most carefully about. But as I was saying before, like with any treatment’s cancer treatments have toxicity, that’s a common problem. So, and when you’re dealing with something brand new sometimes there is a little bit more risk. So, when you’re talking about these very early-stage Phase I trials you probably want to talk to your doctor about what sorts of toxicities you can expect and where they are in the Phase I trial. Are you the first ever to receive this new drug? And if you are nobody’s making you go in the clinical trial, so it can only help to get more information. Right? So, you should ask your team about it, you should find out.

Most of the time there’s going to be a lot of patients that have been treated already, I mean, they can’t give you definitive data about how things are going but they can maybe say, “Hey. I’ve already treated a few patients on it, and they seem to be doing great.”

Katherine Banwell:

So, you need to weigh the pros and cons of the trial.

Dr. Seth Pollack:

You do need to weigh the pros and cons. Now, when you’re talking about these Phase IIs and Phase IIIs, I mean, these are drugs now that have really been vetted for their safety and we have a lot of data about it. And even the Phase Is, it’s not like these things are coming out of nowhere, they’ve been scrutinized, we really expect that they’re going to be safe but we’re doing the trial to prove it. So, it’s a good thing to ask about.

Katherine Banwell:

Yeah, yeah.

Sujata Dutta:

Yeah. I would also add that it’s so closely monitored that safety is a top priority, it’s front and center. So, the advantage, I think, with being on a trial is the close monitoring of the patient exactly for this reason.

If something is amiss it’s going to be picked up as quickly as possible and you’re any issues are going to be addressed as soon as. So, I think, safety does get addressed pretty quickly.

Katherine Banwell:

Good.

Can data from trials even be trusted? Dr. Pollack, is that the case?

Dr. Seth Pollack:

Well, of course, I mean, it can be trusted. Because the thing with the clinical trial data is that you really see the data and there’s all kinds of scrutiny making sure that the data is reported accurately. Now, there’s a whole other conversation we could have as to whether we could interpret the data differently. And sometimes that is an issue that comes up, but the data is reported very accurately.

So, and there are statistics that are very well understood, and the bar is actually pretty high to say one arm of the trial was better than the other arm of the trial. So, if patients have better survival on one arm, if we say that, usually it means they did considerably better. Enough better that it wasn’t a random chance that one extra patient did better on the treatment arm. No. There were enough patients that did better that the statisticians can go through it with a fine-toothed comb. And they can be absolutely sure up to exactly how many percent sure they can tell you, 0.05 percent or less chance of error that this was a real difference between the study arm and the standard of care arm.

Sujata Dutta:

I think you mentioned too that one is trust, and one is data. So, Dr. Pollack mentioned a lot about the data, I think the trust is also a very important thing. I like to go with positive intent because I do not have a reason to believe my doctor has some ulterior motive to suggest a clinical trial. And so, I trust them wholeheartedly. The first hurdle is you have to trust the system or what is being proposed to you because, as Dr. Pollack said, it’s gone through a lot of vetting. A recommendation to be part of a trial itself is vetted by your doctor when they make the recommendation. So, have faith, trust, that they are making a good recommendation. And then, of course, the data, I don’t know much about that, but as I said, I trust it. So, I would trust the data too.

Katherine Banwell:

Of course. Of course. Some patients feel like they’re going to lose their privacy. Sujata, did you feel that at all?

Sujata Dutta:

No. Not at all.

I mean, with everything else that is also taken care of, my information, or whatever, is not made available to anybody. And so, obviously there’s a lot of people will get those, and I had a huge pile of paperwork to go through, but I think that’s a good thing. For my peace of mind that I knew that my information was not going to be shared outside of the study, the trial, etc., and things. So, no, I don’t think that’s a problem.

Katherine Banwell:

Beyond these misconceptions is there anything else you hear? Dr. Pollack?

Dr. Seth Pollack:

No. I mean, look, in our crazy modern world there’s concerns everywhere, but the clinical trial is very, very careful. Whenever possible we use the medical chart.

And then, we have a very stringently protected database that’s storing people’s information, but it’s deidentified. So, I mean, we have a separate key to figure out who the patients are and then we try to limit the use of the patient’s name or any identifying information about them beyond that. So, and your information is not shared. For example, if there’s a drug company involved in the trial, your information is not shared with the drug company, you have a new identifier that is unique and not traceable back to you that is provided to whoever, if there’s outside groups working on the trial with you. So, your information is very carefully protected, and everyone is very conscious about issues regarding privacy.

Katherine Banwell:

That’s great to know.

Are Clinical Trials a Logistical Nightmare?

Are Clinical Trials a Logistical Nightmare? from Patient Empowerment Network on Vimeo.

PEN board member and myeloma survivor Sujata Dutta shares how her family managed the logistics of her clinical trial participation.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

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Is a Clinical Trial a Last-Resort Option?

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Transcript:

Katherine Banwell:

The logistics will be a nightmare and I don’t live close to a research hospital. Sujata, did you have that issue?

Sujata Dutta:

Yeah. That’s a very interesting one, and actually I’ll share my experience. I did have this concern about logistics, because I got my transplant at Mayo Rochester, which is a two-hour drive from where I live. And so, when I got to know about it literally me and my husband were like, “Oh, my gosh. What are we going to do?” It’s not just me, my husband is my caregiver, he has to take the day off to drive me to Mayo, wait through my treatment, and drive me back. Then we have boys who were distance learning at the time, and so what do we do with them? Do we drop off a friends or take a favor from a friend? And so on and so forth.

So, the logistics was an issue and we literally said, “Thanks but no thanks” and we walked out of the room. And we came downstairs, and my husband was like, “What the heck?” My team understands everything, and I fortunately work for a very good employer, and they understand everything, people first. And so, he was like, “I can figure this out. Let’s do it if this is what’s going to help you, then let’s just figure this out.” And at that time, it was so good, and I have total respect for Dr. Pollack.

You and everybody in this medical community. My doctor who leads the trial at Mayo, she actually said, “Why don’t you check with your local cancer center? Maybe they are also approved by FDA, and they may be able to administer this treatment to you.” Unfortunately, at that time they weren’t but we were like, “We’re going to go ahead with the trial. It doesn’t matter.” My husband was like, “I’ll take the day off, you don’t worry about it.” And then, four months later my institute did get approved by FDA, and so I was able to transfer from Mayo to my local cancer center, Abramson Cancer Center, which is 20 minutes from home. And so, there are options, I know that it can be an issue and it can be overwhelming at the time which was the case with me. But I was able to overcome that, so maybe there are options available that the patients can consider.

Is It Expensive to Participate in a Clinical Trial?

Is It Expensive to Participate in a Clinical Trial? from Patient Empowerment Network on Vimeo.

Is there a financial cost to participating in a clinical trial? Dr. Seth Pollack explains how clinical trials participation is billed and potential financial impacts.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

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Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?

Transcript:

Katherine Banwell:

Is this fact or fiction; it will be expensive? Dr. Pollack?

Dr. Seth Pollack:

That’s fiction because the way the clinical trials work is we go through everything very carefully to figure out what things are standard and what things are unique to the clinical trials. So, if you are getting chemotherapy, you’re going to need blood work, you’re going to need the chemotherapy drugs, you’re going to need some sort of imaging, CT scan, or whatever your doctor would do.

And all those sorts of things are considered standard, so your insurance company is built for those. Then there’s a bunch of things that are considered research. For example, there’s special research bloodwork, maybe there’s an investigational agent that’s being added to standard chemotherapy. Those things are billed to the study, so you don’t actually have to pay anything extra, it’s just like you’re getting the normal treatment as far as you’re concerned. I mean, that’s the way it always is, and I haven’t had any of my patients ever get into real problems in terms of the finances of these things. It always works very straight forward like standard therapy.

Is a Clinical Trial a Last-Resort Option?

Is a Clinical Trial a Last-Resort Option? from Patient Empowerment Network on Vimeo.

Are clinical trials only meant as a last-resort option? Dr. Seth Pollack debunks this common clinical trial misconception and explains why he feels patients should participate when the opportunity arises.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

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Transcript:

Katherine Banwell:

Right. And another concern that people have is; clinical trials are my last resort treatment option. What do you say to that Dr. Pollack?

Dr. Seth Pollack:

Yeah, no. That’s a common misconception. So, we like to have clinical trials for every phase of the patient’s cancer journey because we’re trying to make every single part of the cancer journey better. So, I think a lot of people think that, okay, when they hit their last resort that’s kind of the time to try something new. Even in the very earliest parts of the cancer journey, even in the diagnosis phase sometimes we’ll have clinical trials where we’ve tried different images, modalities, or look at things in a different way in terms of the biopsies.

But then, in terms of the cured-of treatments, when somebody is in the cured-of setting we don’t usually try something very brand new. But a lot of the times we’ll try something that is very affective for patients at the end, and we want to try and make the cured-of strategy even better. So, a lot of the times for those patients we’ll have new therapies that are very safe and established that we’re trying to incorporate earlier into patients’ treatments because we know they work really well, right? And then, even in patients who have incurable cancer a lot of times it’s better to try a clinical trial earlier on just because sometimes the clinical trials have the most exciting new therapies that are bringing people a lot of hope.

And a lot of the times you want to try that when you’re really fit and when you’re in good shape. So, that’s why I think that you really want to think about doing a clinical trial when the opportunity arises.

Katherine Banwell:

Yeah. Beause it could be beneficial to you and it’s certainly going to be beneficial to other people.

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

If I Participate in a Clinical Trial, Will I Be a Guinea Pig? from Patient Empowerment Network on Vimeo.

Does participating in a clinical trial make you a “guinea pig” for new treatments? Clinical researcher, Dr. Seth Pollack, provides a clear explanation of clinical trial safety protocols.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

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Transcript:

Katherine Banwell:

Well, I’d like to address a list of common concerns about clinical trials that we’ve heard from various audience members prior to this program.

And this is probably the most common; I will be a guinea pig. Dr. Pollack, how do you respond to that?

Dr. Seth Pollack:

Yeah. I know that is a common concern. I mean, I think the thing that people have to understand about clinical trials is there is just so much oversight that happens for these clinical trials. Every document, every procedure, is scrutinized by multiple committees. There’s a scientific review committee, there’s a review board, IRB, that reviews these. Many of these trials are reviewed by the FDA and they’re reviewed by your doctor and your doctor’s colleagues that are also participating in the trial. So, every detail is discussed at length.

In fact, a lot of the times there’s a lot more structure to being on the clinical trial than just routine clinical care because they’ve thought so thoroughly about when everything needs to be done and what the right timing of is for the various procedures.

A Patient Shares Her Clinical Trial Experience

A Patient Shares Her Clinical Trial Experience from Patient Empowerment Network on Vimeo.

Sujata Dutta, an empowered patient advocate, explains why she felt participating in a clinical trial was the right decision to treat her myeloma.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

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Transcript:

Katherine Banwell:

Sujata, I understand that you went through a series of treatments for your multiple myeloma, which is a type of blood cancer, including a stem cell transplant.

At what point did you and your doctor consider a clinical trial might be best for you?

Sujata Dutta:

Yes, you’re right. I was diagnosed with multiple myeloma in December, and so the line of treatment or the standard protocol is that you go through what is called an induction therapy. Which is like a few cycles of chemotherapy which get you ready for a transplant. And the transplant, the hope is that it kind of washes away, or cleans off all the cancer cells for you, or at least brings the cancer to a very, very minimal level. And I did go through six rounds of chemo which got me ready for the transplant, and I went through the transplant in June of 2020. However, I’m amongst the very few, small percentage of people that just did not respond with the transplant. So, I was at the same point as where I started. So, it was a little bit disappointing, but my doctors were there to help me understand the situation. It was a hard pill to swallow.

But anyways, there were options. And that’s what I feel very hopeful about with multiple myeloma is that there are so many options available today through treat, or to at least bring the disease under control to a very large extent. And I expressed a desire to be in a trial very earlier on, so my doctor did know that I would lend a year or two listening to what the trials were. And it just so happened that there was a trial that was very apt in my situation, somebody who had gone through a transplant. They have some criteria, and I was able to meet that criteria. And so, for me, it seemed to be the right decision to make. And so, that’s how I agreed to be part of the trial.

Katherine Banwell:

Can you go into some detail about why you thought a clinical trial was a best thing for you?

Sujata Dutta:

Yeah. So, initially before knowing much about the strain that I’m a part of, I just had the desire to be part of a trial because I was always in awe of patients who had been in trials before me.

And because of whom I was benefiting. But whatever regiments, medications, combos, whatever was happening. And so, from that perspective I always wanted to give back in some way. Unfortunately, we are having more people being diagnosed with cancers, with multiple myeloma, and so I was very motivated to do something for the community that I was now part of. And so, I had my transplant at Mayo, and I knew that they had a whole bunch of trials and had access to different types of trials. So, that was my first motivation and it just so happened that, as I said, my experience with transplant didn’t go the desired way. And so, when I heard that there was a possibility that I could be part of a trial, I kind of leaned into actually agreeing to be part of that.

Katherine Banwell:

Yeah. It sounds like that was the next step for you.

Sujata Dutta:

Yup.

What Is a Clinical Trial and What Are the Phases?

What Is a Clinical Trial and What Are the Phases? from Patient Empowerment Network on Vimeo.

How do clinical trials work? Dr. Seth Pollack, a clinical researcher, defines clinical trials and explains what occurs in each of the phases.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

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Transcript:

Katherine Banwell:

Let’s start with a basic question, Dr. Pollack. What is a clinical trial?

Dr. Seth Pollack:

Yeah. It’s a basic question, but actually, sometimes, it can be harder to answer than you might think.

I think everybody has an idea in their mind about what a clinical trial is, you’re going to test a new approach. But actually, there’s a whole variety of different things that can be a clinical trial, right? A clinical trial a lot of the times is testing a new drug, could be testing something for the very first time, could be testing something in combination with other drugs for the very first time. It could be testing a standard approach but doing it in a new way. It could even be giving less treatments than we usually do. For example, if there’s a very intense, harsh, standard of care treatment we might even have a clinical trial where we try a little bit less and see that patients do just as well. So, all of those things are clinical trials, but really the clinical trial in its heart is a very organized and careful approach to testing a new treatment strategy for patients.

Katherine Banwell:

Okay. What are the phases of a clinical trial?

Dr. Seth Pollack:

Yup. So, the Phase I clinical trial is usually when we’re testing something for the first time in however we’re doing it. So, it could be the first time we’re testing a new drug, or the first time we’re testing a drug in combination with other drugs. And the real thing about a Phase I trial is that the main goal of the trial is to look at the safety and tolerability of the regiment. That doesn’t mean that we’re not really trying to figure out if the regiment works, I mean, that’s also one of the most important things. But the most important thing for a Phase I trial is making sure that it’s safe and tolerable. A Phase II trial is where we, sort of, shift and we’re still making sure, and double checking, that the drug is, but now our main focus becomes on the efficacy of the strategy.

So, now we’re trying to really figure out if this is a strategy that seems affective enough to go to a Phase III. And a Phase III is a big multi-center trial. Frequently those will be placebo controlled where a lot of the times there’ll be randomized trial where we really try to absolutely prove, beyond a shadow of a doubt, that, that strategy is affective. And those are most of the types of trials that patients will encounter.

Katherine Banwell:

Okay. Thank you for providing clarity around the phases.

How Can Patients Access the Latest DLBCL Treatment Options?

May 11, 2022/in Diffuse Large B-Cell Lymphoma (DLBCL), DLBCL Newly Diagnosed, DLBCL Programs, DLBCL Toolkit, DLBCL Treatment TK, DLBCL Treatments and Clinical Trials, DLBCL Videos ND, DLBCL Videos TC /by Kara Rayburn

How Can Patients Access the Latest DLBCL Treatment Options? from Patient Empowerment Network on Vimeo.

How can diffuse large B-cell lymphoma (DLBCL) patients learn more about developing research and new treatments? Dr. Justin Kline provides key advice to access the latest treatment options.

Dr. Justin Kline is the Director of the Lymphoma Program at the University of Chicago Medicine. Learn more about Dr. Kline, here.

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Transcript:

Katherine:

With all of these treatments in development, how can patients ensure that they’re receiving the latest treatment options?

Dr. Kline:

Yeah. It’s complicated, even for somebody who’s in the business. There are so many clinical trials going on all over the place and at various stages. I think, as I mentioned early on in our conversation, one of the best ways to make sure that you or your loved one is receiving the most advanced care is to get that second opinion, particularly at a center that does clinical trials. And it doesn’t have to be an academic center. There are many offices in the community that also run clinical trials, but I think meeting with somebody who treats DLBCL for a living at least once to talk about those options is a good idea.

The second approach is really to get engaged. And it may not be the person with lymphoma, sometimes it’s a spouse or a child, usually a grown child, but doing due diligence, getting involved with websites, Lymphoma Research Foundation, Leukemia-Lymphoma Society, where you know you’re getting good information. Folks like you guys who are involved in patient education. I think I have seen many patients who come in extraordinarily well educated about DLBCL, even before their first visit, and I do think it does make a difference in helping them decide what and where they want to get their treatment.

Katherine:

Yeah. What resources would you recommend for patients to help them stay up to date or to learn more about their disease?

Dr. Kline:

Sure, yeah. Again, I think as folks sort of meet with their oncologist or oncology nurse, each office or center may have their own specific recommendations. I really like, as I mentioned, the Lymphoma Research Foundation, which I think is LRF.org*, the Leukemia & Lymphoma Society, LLS.org. They not only have a website that has a lot of information on it, but they often have patient education days once or twice a year where specific lymphomas are discussed in their treatment, that’s geared toward people with lymphoma and their caregivers.

They also have, it talks about dealing with chemotherapy, the financial toxicity associated with cancer treatments, how to sort of share your diagnosis with your children and other family members, so it’s not just doctors that are barking at you all day long, but it’s other people, social workers, lawyers, nutritionists, nurses. So, those are probably my two favorite organizations, but there are many others where people can get very good and useful information about DLBCL and other lymphomas as well.

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Which Emerging DLBCL Therapies Are Showing Promise? from Patient Empowerment Network on Vimeo.

What’s next in diffuse large B-cell lymphoma (DLBCL) treatment? Dr. Justin Kline reviews developing research that could transform the future of DLBCL treatment.

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Transcript:

Katherine:

What about emerging therapies, Dr. Kline? What approaches are showing promise?

Dr. Kline:

Well, I think probably in DLBCL, the biggest breakthrough, I don’t even know that I can call it emerging at this point, because it’s on the market, so to speak.

But I think it’s important to talk about, again, is CAR T-cell therapy, and this is a type of immune therapy where a person’s own immune cells called T-cells are taken from his or her bloodstream. And then using a special type of a virus, those T-cells are manipulated or engineered, that sounds better, to express on their surface something called a chimeric antigen receptor, which is somewhere between an antibody and a normal T-cell receptor. But anyhow, this chimeric antigen receptor confers or allows the T-cell to recognize a protein that’s expressed on the surface of B-cells, cancerous or otherwise, called CD19. And when that chimeric antigen or CAR antigen, excuse me, that CAR receptor expressing T-cell sees a lymphoma cell, it engages it and kills it, a pretty clever idea which has been in the works for decades now.

But CAR T-cell therapy has now been approved for not only DLBCL but many other types of non-Hodgkin lymphoma. And I think in the past decade, far and away, that’s the biggest breakthrough. There are other types of immunotherapy, probably most notably a type called bispecific immunotherapy, which is a pretty clever type of immune therapy where these specially engineered antibodies that are capable of binding or sticking to not only a person’s T-cell, a T-cell that’s already in his or her body, and a B-cell, a lymphoma cell that’s right next to that T-cell, sort of holds them together, and the part that binds the T-cell actually activates it, triggers it to kill the B-cell. And so there are a number of companies that have those bispecific therapies that are in development. I suspect a couple will be approved by the FDA, I would guess, in 2022.

These bispecific immunotherapies have been very effective, again, in DLBCL that’s come back, relapsed or refractory, as well as in other lymphomas. They do have some side effects that are similar to what we see in folks with CAR T-cell therapy. I won’t belabor what those are, but they are also very effective. There’ve been a number of drugs that, either immunotherapies or other types of therapies, that target that same CD19 protein on diffuse large B-cell lymphoma cells that have recently been approved by the FDA, either alone or in combination. Targeted therapies are always exciting. Although as compared with other lymphomas, these targeted therapies, many of which are oral, which are pills, have not been particularly effective in relapsed DLBCL.

So, I think that among the most exciting therapies are those that take advantage of our own immune systems to recognize and kill the lymphoma cells.

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How Is Relapsed/Refractory DLBCL Treated? from Patient Empowerment Network on Vimeo.

What options are available if a diffuse large B-cell lymphoma (DLBCL) patient doesn’t respond to treatment or relapses? Dr. Justin Kline discusses potential next steps in treatment for DLBCL patients with relapsed or refractory disease.

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Transcript:

Katherine:

Let’s talk about if someone doesn’t respond to initial treatment or they relapse. Let’s start by defining some terms for the audience. What does it mean to be refractory?

Dr. Kline:

So, refractory is a term that’s used to describe a situation where a person has received treatment but that treatment hasn’t worked as well as we have expected. And the most – probably the most important scenario is after initial treatment.

Most people, for example, who receive R-CHOP, somewhere between 80 and 85 percent will have a completely negative PET scan after treatment. That’s remission. If the PET scan is not negative and you do a biopsy and it shows that there’s still lymphoma there, that’s what’s called primary refractory. In other words, the person’s lymphoma was refractory to initial or primary treatment. And in clinical trials that are testing agents, drugs or immunotherapies in folks who’ve had multiple treatments, usually refractory is used to define someone who has either not responded or has had a very, very short response to whatever the last treatment they had was.

Katherine:

How does relapse then differ from refractory?

Dr. Kline:

So, right, so relapse suggests that the lymphoma at some point was in a remission, right?

And so for example, a person gets six treatments of R-CHOP, has a PET scan at the end, the PET scan is clean. We say you’re in remission. Eight months later, the person develops a newly enlarged lymph node, and a biopsy shows that the lymphoma has come back, right? That’s what we would call a relapse. There was a period of remission, whereas refractory usually means there was never a period of remission to begin with.

Katherine:

Got it. How typical is it for a patient to relapse?

Dr. Kline:

Well, again, if you look at all comers, if you treated 100 people with DLBCL, most, probably 70 to 75 percent, would go into remission. About 10 or 15 percent would have primary refractory disease and another 10 or 15 percent would have a remission that would end at some point and they would have a relapse. So, it’s not terribly common.

The problem is that once the lymphoma has either demonstrated that it’s refractory to treatment or it’s come back, it’s relapsed, it’s a little bit more difficult to cure the lymphoma at that point.

Katherine:

How are patients treated then if they’ve relapsed or refractory?

Dr. Kline:

Well, so for somebody who’s had primary refractory lymphoma or has a lymphoma that’s relapsed after initial therapy, again, say for the sake of argument with R-CHOP, for many, many years, the next line of treatment if you will was to administer what we call salvage chemotherapy, and this is different chemotherapy from the original R-CHOP, that’s meant to put the lymphoma back into remission. In other worse, to salvage a remission. And for folks whose lymphomas were sensitive or responded, shrunk down to that salvage chemotherapy, we would consolidate that remission.

We would make it deeper using high dose chemotherapy and an autologous or a cell, stem cell transplant. And that’s been the standard of care for younger patients for decades.

That paradigm has been challenged, particularly in refractory patients or those who have very early relapses after R-CHOP, by two important clinical trials that have demonstrated superiority of a type of immunotherapy, a cellular immunotherapy called CAR T-cell therapy, which seems to be more effective even than stem cell transplantation in that population of folks.

How Is DLBCL Treatment Effectiveness Monitored?

May 11, 2022/in Diffuse Large B-Cell Lymphoma (DLBCL), DLBCL Newly Diagnosed, DLBCL Programs, DLBCL Toolkit, DLBCL Treatment TK, DLBCL Treatments and Clinical Trials, DLBCL Videos ND, DLBCL Videos TC /by Kara Rayburn

How Is DLBCL Treatment Effectiveness Monitored? from Patient Empowerment Network on Vimeo.

How will patients know if their diffuse large B-cell lymphoma (DLBCL) treatment is working? Dr. Justin Kline defines DLBCL treatment goals and explains how they are monitored throughout the treatment process.

Dr. Justin Kline is the Director of the Lymphoma Program at the University of Chicago Medicine. Learn more about Dr. Kline, here.

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Which Emerging DLBCL Therapies Are Showing Promise?

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$How Is Relapsed/Refractory DLBCL Treated?$

How Is Relapsed/Refractory DLBCL Treated?

Transcript:

Katherine:

Let’s turn to what happens after treatment. How is the effectiveness of the treatment monitored?

Dr. Kline:

Well, so depends on the doc to some degree, but I like to do some, what I call interim imaging. So, we’ll typically, again, depending on the stage, but very often we’re delivering six treatments of R-CHOP, usually given every three weeks. So, the total treatment course is about four and a half months. It can be a little bit shorter for patients who have Stage 1 or Stage 2 DLBCLs. I like to get interim imaging, which is either a PET scan or a CAT scan, done sort of in the middle of treatment, just to give us a sense of how things are going. Are the lymphomatous tumors shrinking down? Some patients are, even by the middle of treatment, are in a complete remission. Their PET scan has gone totally normal. And then at the end of treatment, that’s probably the most important imaging, and there I do like to do PET scans again. Again, they’re the most sensitive test we have to detect lymphoma.

And so at the end of treatment, usually about four to six weeks after somebody completes treatment, we like to get that end of treatment PET scan, and that’s the PET scan that allows us to say, you’ve had a complete response. You’re in a complete remission, or not.

Katherine:

So, what does remission mean exactly then?

Dr. Kline:

So, in DLBCL, remission is pretty simply defined as absence of disease on, or absence of cancer on the tests that we do to detect it. Again, typically PET scans, and if somebody had involvement of his or her bone marrow at the beginning before treatment, we’ll repeat that bone marrow at the end of treatment just to make sure that there’s no lymphoma left over. And so, but for most people it’s a PET scan. If the PET scan does not show any abnormalities, then that’s what we call a complete remission or remission.

Katherine:

Is a cure possible for patients with DLBCL?

Dr. Kline:

Cure is not only possible, it’s actually quite common. If you look at all comers, regardless of stage, age, what have you, approximately 60 to 65 percent of folks who are treated for DLBCL are cured. The cure rates are higher with folks with earlier stage lymphomas, but even folks who have advanced DLBCL are frequently cured.

Which Factors Impact DLBCL Treatment Decisions?

May 11, 2022/in Diffuse Large B-Cell Lymphoma (DLBCL), DLBCL Newly Diagnosed, DLBCL Programs, DLBCL Toolkit, DLBCL Treatment TK, DLBCL Treatments and Clinical Trials, DLBCL Videos ND, DLBCL Videos TC /by Kara Rayburn

Which Factors Impact DLBCL Treatment Decisions? from Patient Empowerment Network on Vimeo.

When making a decision about diffuse large B-cell lymphoma (DLBCL) treatment, what should you consider? Dr. Justin Kline reviews key patient factors that impact therapy decisions, including comorbidities and treatment side effects.

Dr. Justin Kline is the Director of the Lymphoma Program at the University of Chicago Medicine. Learn more about Dr. Kline, here.

Related Programs:

Which Emerging DLBCL Therapies Are Showing Promise?

How Is DLBCL Treatment Effectiveness Monitored?

$How Is Relapsed/Refractory DLBCL Treated?$

How Is Relapsed/Refractory DLBCL Treated?

Transcript:

Katherine:

Other than a newly diagnosed patient’s stage of DLBCL and their age, what other factors would impact a treatment decision?

Dr. Kline:

Yeah. So, that’s a good question, so you named I think the biggest two, the most important two. Although I have to say that even people in their – oftentimes in their 80s are prescribed full dose therapy. The goal of our treatment, especially in newly diagnosed patients, is to cure the lymphoma, and so we tend to be aggressive. But outside of age, other things we consider are other health problems. Does the person have a healthy heart, healthy kidneys? How many other medical problems does the person have? How fit is the person? How sick is the person or symptomatic is the person from his or her lymphoma? And sometimes we take into consideration all those factors and we say, well, it’s still worth it to try to deliver the most intensive therapy that we can.

Other times we say, you know what? I think the risk of doing such is probably not worth the potential benefit, and so sometimes we’ll recommend dose reductions, reduce the doses of some of the medicines and the R-CHOP cocktail if that’s what we’re going to do, and occasionally, if the person has too many other things going on, we may talk about more palliative treatments, in other words, gentler treatments that may extend a person’s survival while hopefully maintaining a really good quality of life.

Katherine:

Yeah. What kind of side effects should patients expect?

Dr. Kline:

Well, that’s a conversation I’ve had many, many, many times over the years. And specifically to the R-CHOP cocktail, just because that’s the one that’s used most commonly, I tell people that the most common things are symptoms like fatigue, occasionally nausea, sometimes vomiting, although the medications we have to prevent those things are very good these days.

Constipation is not uncommon, hair loss, mouth sores. I think probably the most important thing is to recognize that the chemotherapy will suppress or reduce the immune system, and so we’re always worried about people catching infections when they’re on chemotherapy, because sometimes they can be serious. And then I talk about rare symptoms that are a big deal. Sometimes the chemotherapy can damage organs like the heart. It’s uncommon, but it happens sometimes. And chemotherapy, while we need to give it to cure the lymphoma, can sometimes cause secondary blood cancers like leukemias years down the road. The risk is low, but again, these are I think serious things that people, even if they’re rare, people need to know about them before they start.

How Is DLBCL Treated?

May 11, 2022/in Diffuse Large B-Cell Lymphoma (DLBCL), DLBCL Newly Diagnosed, DLBCL Programs, DLBCL Toolkit, DLBCL Treatment TK, DLBCL Treatments and Clinical Trials, DLBCL Videos ND, DLBCL Videos TC /by Kara Rayburn

How Is Diffuse Large B-Cell Lymphoma (DLBCL) Treated? from Patient Empowerment Network on Vimeo.

Dr. Justin Kline explains what patients need to know about current DLBCL treatment, including R-CHOP, stem cell therapy, and clinical trials.

Dr. Justin Kline is the Director of the Lymphoma Program at the University of Chicago Medicine. Learn more about Dr. Kline, here.

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Which Factors Impact DLBCL Treatment Decisions?

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Transcript:

Katherine:

From what I understand, treatment really should start right away. So, what types of treatment are currently available to someone newly diagnosed with DLBCL?

Dr. Kline:

Sure, so for about 20 plus years now, the standard of care for most patients with DLBCL, regardless of whether it’s a germinal center or an activated B-cell type DLBCL, is a combination of what we call chemo immunotherapy, the acronym for which is R-CHOP, and each of those letters stands for a different medication. The R stands for rituximab, which is an antibody that coats the surface of lymphomatous B cells and sort of signals the immune system to come and kill those cells.

The C is cyclophosphamide, the H is hydroxy doxorubicin, and the O is Oncovin. These are each classical chemotherapy drugs, and they each work through a different mechanism to help kill lymphoma sells. And the P is a steroid pill called prednisone, so it’s a little bit complicated, but the reason that we use cocktails of medicines to treat lymphomas is that it really works to prevent the lymphoma cells from gaining the upper hand, from developing resistance to a single type of treatment.

Katherine:

Right.

Dr. Kline:

Now, I should say that for certain DLBCLs, particularly those double hit lymphomas that we talked about, sometimes we use a more intensive cocktail called dose-adjusted R-EPOCH. It has largely the same medications with an additional chemotherapy called etoposide.

The difference is that R-CHOP is given – all the drugs are given intravenously, with the exception of prednisone, over a single day. The dose-adjusted R-EPOCH is given over an infusion over the course of about five days. The other point I might make is that there was a recent large clinical study that compared R-CHOP to a new regimen called polatuzumab R-CHP. So, basically the O in R-CHOP was removed and substituted for this new drug called polatuzumab vedotin, and although many, many combinations similar to R-CHOP have been compared to R-CHOP over the past 20 years and failed, this regimen, polatuzumab R-CHP in the study called the POLARIX study actually was shown to improve what we call progression-free survival by about six percent. So, it may become a new standard of care for treating DLBCL, which is exciting, because we haven’t had one in over 20 years.

Katherine:

Right. That’s good news.

Dr. Kline:

Long answer to a short question, sorry about that. Yes, it is good news.

Katherine:

That is good news. What about stem cell transplants?

Dr. Kline:

Good question. So, for newly diagnosed patients, in this era, we rarely if ever are recommending stem cell transplant or stem cell transplantation as part of initial therapy. There are rare circumstances, but for the vast majority of patients who are, people who are diagnosed with DLBCL, it’s not recommended.

Katherine:

Where do clinical trials fit in?

Dr. Kline:

It’s a really good question. I practice at an academic medical center, and so one of our missions is to advance therapy and make it better. There’s no way to do that without performing clinical trials, so I think for – clinical trials aren’t for everyone. As a matter of fact, most people with lymphoma are not treated in the context of clinical trials.

But certainly I think they are important to consider, and number one, it’s possible that the particular person might be involved with the clinical trial that is very successful and actually improves their outcome. I always tell people that I see that being involved with the clinical trial is also, to some extent, an altruistic endeavor. You’re helping your doctors learn more about how to treat a type of cancer, hopefully better, maybe not, you know? So, there is some altruism that goes into clinical trials as well. So, I do think that most people who are able should consider having a second opinion. Doesn’t have to be at an academic medical center, but at least with another doctor, where clinical trial options can be discussed.

An Expert Defines Diffuse Large B-Cell Lymphoma (DLBCL)

May 11, 2022/in Diffuse Large B-Cell Lymphoma (DLBCL), DLBCL Basics TK, DLBCL Newly Diagnosed, DLBCL Programs, DLBCL Toolkit, DLBCL Treatments and Clinical Trials, DLBCL Videos ND, DLBCL Videos TC /by Kara Rayburn

An Expert Defines Diffuse Large B-Cell Lymphoma (DLBCL) from Patient Empowerment Network on Vimeo.

What is diffuse large B-cell lymphoma? Dr. Justin Kline defines DLBCL from symptoms to staging and explains how the condition progresses through the body.

Dr. Justin Kline is the Director of the Lymphoma Program at the University of Chicago Medicine. Learn more about Dr. Kline, here.

Related Programs:

How Is DLBCL Treated?

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Transcript:

Katherine:

Let’s start by understanding what DLBCL is and how it progresses. How would you define DLBCL?

Dr. Kline:

Well, diffuse large B-cell lymphoma is a malignancy of a normal counterpart cell called a B-cell, which is part of our immune system. Its job is to make antibodies, to help protect us from various types of infections. Diffuse large B-cell lymphoma, or DLBCL, initiates when normal B-cells acquire changes in their genetic machinery, like any cancer. And DLBCL is the most common form of non-Hodgkin lymphoma. We classify it as aggressive, as an aggressive lymphoma, which means if left untreated it tends to grow pretty quickly.

Katherine:

How is it typically diagnosed?

Dr. Kline:

Well, it varies. But like any cancer, a diagnosis requires some sort of a biopsy, either a surgical removal of a lymph node or a needle biopsy of a lymph node or another structure where the tumor seems to be growing.

Katherine:

How does somebody know if they have DLBCL?

Dr. Kline:

Well, there are certain symptoms that are more common amongst folks with DLBCL. And they’re not specific to DLBCL, they can be seen in other lymphomas, but they include symptoms like fatigue that’s unrelenting, unintentional weight loss, sometimes fevers, typically at similar times throughout the day, drenching night sweats, swollen lymph nodes, and then certainly pain in any area of the body that comes and doesn’t go. Those are some of the general symptoms.

Katherine:

And how does the condition progress?

Dr. Kline:

Well, as I mentioned, DLBCL tends to be an aggressive lymphoma, so sometimes folks will notice enlarged lymph glands that continue to grow and grow and grow. Sometimes they’re painful, sometimes not so much. DLBCL, it can really grow anywhere, so we think of it as a lymphoma and so involving lymph nodes, but DLBCL can grow in any organ, even outside of lymph nodes. And so it sometimes progresses locally, but it also can spread and start to grow in other areas of the body.

Katherine:

And how is it staged, Dr. Kline?

Dr. Kline:

Well, there’s a special staging system for all lymphomas that is somewhat similar to what folks might think of with solid tumors like a breast cancer, a lung cancer. But in other ways, it’s different.

The staging tools for DLBCL are really most importantly PET scans and CT scans, really PET scans and in some cases bone marrow exams or bone marrow biopsies. The PET scan is a very sensitive scan that uses radioactive glucose to identify very sensitively where in the body lymphoma might be growing, because lymphoma cells really preferentially prefer to use glucose as their primary energy source. So, they preferentially take up the radioactive glucose that’s given through the vein before the PET scan is taken.

As I mentioned, in some cases, a bone marrow test is also done, although less and less frequently. Which is good, because that’s a more invasive and uncomfortable test. And so folks who have early stage DLBCL that typically involves one lymph node group, like for example, a lymph node in the neck or several lymph node groups on the same side of the breathing muscle, of course you can’t see my breathing muscle here, called the diaphragm.

Those are stage I and stage II DLBCLs. stage III DLBCLs are those that involve lymph nodes on either side of the breathing muscle, so in other words, lymph nodes involved in the neck and then maybe in the groin area, where stage IV DLBCLs are those that involve sites outside of lymph nodes like the liver or the lungs or the bones.

Katherine:

What are the subtypes of DLBCL?

Dr. Kline:

Well, that’s a good and somewhat complicated question. So there, probably most importantly, there’ve been two subsets, if you will, of DLBCL identified, and they really have to do with where along the normal maturation course a B-cell becomes lymphoma or where the DLBCL develops in that normal maturation course. Some DLBCLs arise from what we call germinal center B-cells, which are B-cells that are sort of just seeing their natural antigen or what they’re supposed to recognize.

And then there are DLBCLs that arise in more differentiated or more mature B-cells, and those are called activated B-cell type DLBCLs. So, there’s germinal center and activated, the B-cell type DLBCLs. And I don’t know that that’s super important for your listeners to know, but it is important because these two subtypes of DLBCL are driven by largely separate mutations or alterations in the DNA, and they also respond differently to initial treatment. There are other rare subtypes that involve specific mutations and genes like MYC and BCL2, and these are the so-called double-hit lymphomas. They’re officially classified as high-grade lymphomas, but they’re very similar to DLBCLs. There are other rare subtypes of DLBCL, for example, a type that comes on typically in young men and women called primary mediastinal B-cell lymphoma.

But I think for the sake of simplicity, the most common two subtypes are the germinal center derived and then the activated B-cell type of DLBCL.

Katherine:

All right. That’s good to know, thank you. It helps us understand the disease a little bit better.

Dr. Kline:

Good.

Advice for Speaking Up About Your DLBCL Care

May 4, 2022/in Diffuse Large B-Cell Lymphoma (DLBCL), DLBCL Advocacy TK, DLBCL Newly Diagnosed, DLBCL Programs, DLBCL Toolkit, DLBCL Treatments and Clinical Trials, DLBCL Videos ND, DLBCL Videos TC /by Kara Rayburn

Advice for Speaking Up About Your DLBCL Care from Patient Empowerment Network on Vimeo.

Why should you speak up about your DLBCL care? Dr. Jason Westin explains why being an active member of your healthcare team is vital and provides helpful resources.

Dr. Jason Westin is the Director of Lymphoma Clinical Research in the Department of Lymphoma/Myeloma in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. Learn more about Dr. Westin, here.

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Transcript:

Katherine:

Right. That leads me to my next question. What advice do you have for patients who don’t feel comfortable speaking up but they have questions about their treatment plan?

Dr. Westin:

Yeah. I think written questions sometimes are easier than trying to remember all of your questions. It always is a bit problematic when I go into a visit and a patient has six pages of paper written down for questions. We unfortunately don’t have unlimited time to get through all of those. But trying to condense into – prioritizing. Which of the questions are the ones that I feel like I must get into and which are ones that I can submit to have answered after the fact.

Perhaps the nurse could send me a note through the electronic medical record to answer questions 10-15 on my list. So, I think you can overwhelm a visit if you show up with a list of questions that are even 30-second answers might take an hour to answer all of them. That’s sometimes counterproductive, in my opinion, to have that level of detail on a single visit. But it’s fair to say, “Can I contact the healthcare team to get these answered electronically through the EMR,” or, “Can we table this and go into the questions that we didn’t get to at our next visit?” I think both of those are appropriate.

I think people that are not comfortable to push back on the physician, or the PA, or the nurse, doing things in writing sometimes feels a little bit less confrontational for people. So, I think that’s important to have as a backup option.

Katherine:

And I imagine caregivers can be helpful in this regard as well.

Dr. Westin:

Correct. Yeah. I think caregivers are a key part of that. And sometimes we go into a room and the patient says, “Nope. Don’t have any questions.”

And then, the caregiver has got a whole list of them. That’s very appropriate. Caregivers have that responsibility and that role to play sometimes, to be the key questioner.

Katherine:

Yeah. Are there resources to help patients and their loved ones to weigh the risks and benefits of different treatment options?

Dr. Westin:

There are. There’s lots of resources online and I would make sure that you go to a trusted site. Sometimes things sound too good to be true because they’re not true. But things like the lymphoma research foundation or the LLS, the Lymphoma & Leukemia Society, are great sources for information. And sometimes they may link you to other sites. You could also ask your healthcare provider does their institution have anything specific about this disease. Sometimes your healthcare provider might tell you, “Here’s the right article if you want to go read the source, the clinical trial, that was published to show why this treatment’s good.” They may show you that paper.

But online, careful how deep into the weeds you go because sometimes you can find things that aren’t correct. Trust good, trusted sources.

Katherine:

Do you think patients should consider a second opinion consult with a specialist?

Dr. Westin:

It sometimes is appropriate. Other times, there’s not a lot of time. If treatment’s needed right away, you don’t want to get sicker because you’re waiting for seeing somebody two states over and it takes two weeks to get there. Sometimes you want to start treatment and get the second opinion after you’ve got the fire put out. But the second opinion usually gives more peace of mind than actually changing treatments. But if you’ve got that thought of, “I’m not so sure this is what I’d like to do,” or, “I’d like to get more information,” a second opinion may be very appropriate.

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