Tag Archive for: CLL clinical trials

Developing CLL Research and Treatment News

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Developing CLL Research and Treatment News from Patient Empowerment Network on Vimeo.

CLL expert Dr. Michael Choi provides his perspective on the goals of current CLL clinical trials, discusses approved inhibitor treatments, and shares credible resources to keep up with the latest news in research.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

See More from CLL Clinical Trials 201

Related Resources:

Hesitant to Participate in a CLL Clinical Trial_ What You Should Know

Hesitant to Participate in a CLL Clinical Trial? What You Should Know

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

 How Does Patient Clinical Trial Participation Move CLL Research Forward

Transcript:

Laura Beth:

Dr. Choi, are there recent advances in CLL treatment and research that you are excited about?  

Dr. Choi:

There’s certainly a lot to be excited about as far as new treatments or new understanding of our treatments. What I see as kind of two main aims of trials right now for our patients with CLL, one is to figure out the optimal way to treat patients, especially in the first line of treatment.  

For the past few years, we’ve had two very clear options, two very clear standards, a BTK inhibitor or the combination of venetoclax and a CD20 antibody. And so, right now, there are a couple of trials both in the states and internationally that are for the first time really comparing those head-to-head. At UCSD, we’re eagerly hoping to join one of those trials as well, and so this will help us and help our patients kind of really know which of those options make the most sense for maybe different subgroups of patients.  

I guess the other main emphasis is to have new therapies available to patients in case these existing standards stop working. And fortunately, this is not a common occurrence. Resistance to BTK inhibitors and Bcl-2 inhibitors is not common, fortunately. But we have to be ready with something if that does occur for our patients.  

Certainly, there’s a lot of enthusiasm for the next generation of BTK inhibitors, cellular therapies like CAR-T therapy, and other classes of medications. So, while I hope most of my patients never need those drugs or never need those trials, I think it’s important that we have those available.  

Laura Beth:

How can patients keep up to date on developing CLL research?  

Dr. Choi:

Oh, that’s a great question. I guess I sometimes ask that same question of myself. How can I stay updated on all the developments and discoveries. Yeah, I guess, yeah, certainly talking to your doctors about what other options there may be. Sometimes, that’s maybe the simplest question to ask.

Yeah, I wish online things were a little bit more straightforward. When I go onto clinicaltrials.gov, I pull up hundreds of different CLL trials, some that might not be relevant for all of my patients. I think The Leukemia & Lymphoma Society and other societies and your group as well have done a great job communicating what some of the most promising areas of research are.  

Hesitant to Participate in a CLL Clinical Trial? What You Should Know.

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Hesitant to Participate in a CLL Clinical Trial? What You Should Know. from Patient Empowerment Network on Vimeo.

What should patients know about clinical trials? CLL expert Dr. Michael Choi explains patient trial opportunities and provides key questions to ask about clinical trial participation.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

See More from CLL Clinical Trials 201

Related Resources:

Why Should CLL Patients Consider Participating in a Clinical Trial?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

 How Is a Patient’s Safety Monitored in a CLL Clinical Trial

Transcript:

Laura Beth:

Dr. Choi, what would you say to someone who is perhaps a little hesitant to participate in a trial to encourage them to learn more?  

Dr. Choi:

Yeah, certainly, it’s very natural to be anxious and to be hesitant about entering into a clinical trial about volunteering to receive something that maybe hasn’t been fully tested before. You know, I think when I talk to my patients about trials, one thing I try to keep in mind is that ultimately, to a degree, to a large degree, we have our trials for our patients. We want to have our trials open at our center so that patients that can benefit from them can have access to them.  

And so, a lot of trials are really kind of designed in that way, to give patients a chance at something that we think will be better or a chance to get a drug when other drugs have stopped working. So, I think many clinical trials aren’t really with the thought that we want to prioritize the science and that our patients are just guinea pigs.  

In fact, I think all of us that are treating patients with CLL and being a part of CLL clinical trials, I think we’re really doing our best to prioritize our patients and their health. The trials are really just a part of that. But beyond that, I think maybe the questions that can be asked would be kind of what’s known already about these drugs. 

 Many trials are using drugs that we’ve already used for many years and maybe just using them in a different manner. So, talk to your doctors about what’s already known. Certainly, the question about how will they be monitored, that’s an important question for your team too. And then, certainly, make sure you understand if there are any other options that would be appropriate or good for you and discuss the pros and cons of the trial versus those options. 

How Does Patient Clinical Trial Participation Move CLL Research Forward?

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How Does Patient Clinical Trial Participation Move CLL Research Forward? from Patient Empowerment Network on Vimeo.

Chronic lymphocytic leukemia (CLL) expert Dr. Michael Choi shares how clinical trial participation helps advance research and benefit the CLL community.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

See More from CLL Clinical Trials 201

Related Resources:

Why Should CLL Patients Consider Participating in a Clinical Trial?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

 Hesitant to Participate in a CLL Clinical Trial_ What You Should Know

Transcript:

Laura Beth:

Dr. Choi, why is patient participation in CLL clinical trials so critical to advancing research?  

Dr. Choi:

Yeah, there’s still so much that we can do better for our patients. We’ve come a long way. I think we have a few – many treatments that we can really count on to work when we need it, but I think we still have a way that we can refine this more, which combination to use, which sequence to use, how long to do the certain treatments, and then, of course, what to do if those treatments stop working.  

So, I think, yeah, trials help us answer these questions in kind of formal manners so that the information can be used to help other patients in the future.   

Laura Beth:

I imagine that trial participation benefits the CLL community as a whole, by helping to move the research forward?   

Dr. Choi:

That’s so right, yeah. I’m always humbled and impressed by, I guess, the selflessness and the bravery of some of our patients, or of all of our patients and their families and their loved ones. Volunteering for a trial is certainly no trivial thing, not a trivial thing. And so, yeah, I think that that realization that by being a part of a trial, they’re not only potentially helping themselves and getting good care but also helping the future patients as well.  

How Is a Patient’s Safety Monitored in a CLL Clinical Trial?

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How Is a Patient’s Safety Monitored in a CLL Clinical Trial? from Patient Empowerment Network on Vimeo.

CLL clinical trials have safety protocols, but how are they carried out? CLL expert Dr. Michael Choi explains the frequency of monitoring, what happens if adverse events occur, and the groups that oversee clinical trial safety.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

See More from CLL Clinical Trials 201

Related Resources:

Are CLL Clinical Trials Safe?

 Hesitant to Participate in a CLL Clinical Trial_ What You Should Know

 A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Laura Beth:

Dr. Choi, a lot of patients worry about the safety of a clinical trial. They wonder, “Is it safe, or am I going to be a guinea pig?” What is done to help ensure safety for patients when they’re in a clinical trial? 

Dr. Choi:

Yeah, certainly every clinical trial brings with it or introduces some sense of uncertainty.  

After all, that’s why the trial is being done, because we are trying to learn about how effective or how safe or how tolerable a drug or drug combination is. But certainly, trials are designed in a way that prioritize or emphasize the safety and the monitoring of patients. Oftentimes, trials will have very clear guidance on how often a patient will be assessed, sometimes have very clear recommendations about what to do about each individual lab abnormality that may come up, and certainly very clear guidance on how to adjust the dose of the drugs that are being used if there’s any sort of toxicity.  

But yeah, certainly, I can empathize with the concern that something that’s very new, we may be learning at the same time as our patients as far as what side effects may come up.  

But I do want to emphasize that oftentimes, these aren’t total unknowns, that the research that goes into it, a drug or a pathway, even before the trial starts, gives people a good sense of what things to watch for and how safe things may be.  

Laura Beth:

Is there an oversight committee or a safety committee that reviews the safety information of a clinical trial?  

Dr. Choi:

That’s correct, yeah. Behind the scenes, there are, I imagine, kind of armies of people that are eagerly refreshing their screens to see results come in, both out of excitement to see how something is working, but also to make sure that we’re on top of any side effects or any toxicities that may affect other patients on the trial. Very rarely, maybe a patient on one part of the continent has some side effect, and that information is very quickly and formally disseminated to all the other sites.  

Sometimes, that leads to the other sites deciding to halt their enrollment to figure out what happened and prevent it from happening again, or at the very least, know to keep track of that in our other patients as well. So, yeah, definitely people monitoring things and really, with the priority of keeping other patients safe or keeping all patients safe.  

How Are CLL Patients Monitored After a Clinical Trial Concludes?

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

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

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

See More from CLL Clinical Trials 201

Related Resources:

CLL Clinical Trials: What Are the Phases?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

 How Is a Patient’s Safety Monitored in a CLL Clinical Trial

Transcript:

Laura Beth:

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

Dr. Choi:

Oh, good question. Yeah.  

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

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

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

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

What Happens in Each Phase of a CLL Clinical Trial?

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What Happens in Each Phase of a CLL Clinical Trial? from Patient Empowerment Network on Vimeo.

What are the phases of clinical trials? CLL expert Dr. Michael Choi outlines the research purpose of clinical trials and what happens in each phase.

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

See More from CLL Clinical Trials 201

Related Resources:

CLL Clinical Trials: What Are the Phases?

 
 How Are CLL Patients Monitored After a Clinical Trial Concludes

 How Is a Patient’s Safety Monitored in a CLL Clinical Trial

Transcript:

Laura Beth:

Dr. Choi, can you please walk us through the phases of a clinical trial and what happens during each phase?  

Dr. Choi:

That’s a great question. Yeah, historically, trials have been divided into different phases. The way I think of it is when a drug is first being tested, we don’t want to expose too many people to it, because we’re still learning about the right dose and about its safety. And then, as we learn more and more and maybe get some confirmation that it’s doing what it’s supposed to do, then we have bigger trials and eventually, bring in some comparisons to existing standards.  

So, a Phase I trial is usually, I would say, a few dozen patients, getting the drug for the very first time or sometimes for the first time for this diagnosis. Oftentimes, the very first Phase I trials might have a dose escalation component where the first dose or the first group of patients might get a dose that is based on an assurance that it will be – or some confidence that it will be safe and well-tolerated.  

Then, as the trial goes on, a higher dose will be used once we see that the previous doses are safe. Now, sometimes, this dose escalation happens in between different groups of patients, and sometimes, some trials will escalate the dose for even within an individual patient. But the basic idea of it is to start at doses that we think will be safe and then to gradually escalate it, again, prioritizing the safety of the patients.  

I shouldn’t also – although Phase I trials are designed to determine the safety of a drug, there are many Phase I trials that show clinical activity and benefit to the patients, so I don’t think people should be altogether discouraged from enrolling in a Phase I trial either. 

I can also say that some Phase I trials are just looking at a combination of drugs that we have experience with already, but designed or written as a Phase I trial, because we have to confirm the safety of those two drugs. In those trials, the doses might not be that different than what’s used already, and there’s often more expectation of immediate clinical benefit. Phase II trials are where we’re principally looking or usually looking mainly at the response rate or some sort of clinical endpoint, how many patients get into a partial remission, or how many patients get into a complete remission and so on.  

And I would say these are usually our trials that are 20, 30, 50 patients, to that effect. And basically, from that group of patients, we can get a pretty good estimate of how effective a drug or a drug combination may be. And then finally, the third type of trial, Phase III trial, is when a new drug or a new combination is compared directly to a different – to what would be considered the standard of care at the time.  

So, this is a way that we can get more confidence that this new drug is indeed better than what we’ve been doing up until now.  

How Could CLL Patients Benefit From Clinical Trial Participation?

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How Could CLL Patients Benefit From Clinical Trial Participation? from Patient Empowerment Network on Vimeo.

CLL clinical trials are an option for patients, but what is the benefit of participating in a trial? CLL expert Dr. Michael Choi shares the impact of recent research developments for patients.

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

See More from CLL Clinical Trials 201

Related Resources:

How Does Patient Clinical Trial Participation Move CLL Research Forward

How Does Patient Clinical Trial Participation Move CLL Research Forward?

 Why Should CLL Patients Consider Participating in a Clinical Trial?

 Hesitant to Participate in a CLL Clinical Trial_ What You Should Know

Transcript:

Laura Beth:

Dr. Choi, in your opinion, why should a patient with CLL consider participating in a clinical trial?  

Dr. Choi:

This is definitely a time where there has been a lot of recent progress in the treatment of patients with CLL. The drugs that have been developed in the last few years have definitely been advances, have shown that they are both more effective and more safe than the drugs that we had before.  

So, oftentimes, participating in a clinical trial gives our patients access to some very promising therapies before they’re fully available. Certainly, there are some unknowns and still things to learn about these drugs, so one should be – there are safeguards built into these trials, but I’d say the main thing would be getting access to something that may be better than something that we’ve been using in the past. This applies to somebody getting treatment for the very first time where there may be reasons to think that a new drug or a new combination of therapies will have advantages over things that we’ve been using before.  

And certainly, it is relevant to patients where the existing therapies have somehow stopped working where certainly the trials or experimental agents give us or give our patients a chance to get back in remission.  

What Do CLL Patients Need to Know About Clinical Trials?

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What Do CLL Patients Need to Know About Clinical Trials? from Patient Empowerment Network on Vimeo.

What is a clinical trial and how does patient participation work? This animated video provides an overview of clinical trials, the process, and details key steps for engaging in your care.

See More from CLL Clinical Trials 201

Related Resources:

What Are the Types of CLL Clinical Trials?

 CLL Clinical Trials: What Are the Phases?

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

Transcript:

 Dr. Singh:  

Hi, I’m Dr. Singh, and this is my patient, Elena, who is living with chronic lymphocytic leukemia, also called “CLL.”

And Elena is participating in a CLL clinical trial.  

Let me start by explaining what a clinical trial IS. Basically, it is a research study with human participants. And the goal of cancer clinical trials is to discover new and improved treatments to treat or to prevent cancer. 

At first, when I asked Elena if she would consider participating, she had a few hesitations.  

Elena:

Yes—even though I trust Dr. Singh, I still had questions. 

So, the first thing I asked was, what steps are taken to protect my safety if I participate in a trial? 

Dr. Singh: 

This is a common concern for many patients, and so I explained to Elena that each trial has a strict safety protocol, with set guidelines to protect patients. Beyond that, researchers are required to follow patient safety rules, which are enforced by the U.S Food & Drug Administration (FDA). At each study location, an institutional review board (or IRB) regularly reviews a study, and many trials are overseen by a group called a data and safety monitoring committee. 

And the trial team, which can include nurses and researchers, closely monitors the health of each trial participant regularly, all throughout the process. This is why clinical trials often require more visits and testing, and, in turn, a bigger commitment from that patient.  

Elena: 

After I felt more comfortable about the safety aspects, I asked Dr. Singh which clinical trial he would recommend for my CLL. 

Dr. Singh: 

That’s right. We discussed Elena’s available trial options, reviewed the pros and cons of each approach, as well as the logistics and potential financial impact. 

And it’s important to note that not every patient will qualify for every trial. Clinical trials have “eligibility requirements,” which can vary widely but may include factors like a patient’s age, health, and any prior treatments they have had.  

Elena: 

And there are several phases of clinical trials, right, Dr. Singh? 

Dr. Singh: 

Yes, exactly. The main phases are Phase I, II, III and IV. Each phase gathers valuable information about the treatment and helps measure its effectiveness.  

Elena: 

So, the main reason I joined a trial was to find out if a newer treatment could be more effective than the standard of care to treat my CLL. AND I wanted to help move cancer research forward for the CLL community. 

Dr. Singh: 

Exactly. Not every patient has the same reason for participation, but trials are essential for developing new and improved treatments for the future. 

Elena:  

I also learned that patients can leave a trial at any time or stage if they wish. 

Dr. Singh: 

That’s a great point, Elena.  

Now that you understand more about trials, how can you find out more? 

  • Start by asking your doctor if there are any trials that are available to you—and, if there is a specific trial that they recommend for you. 
  • If there is a trial that your team recommends, ask to discuss: 
  • The treatment approach used in the study and the purpose of the trial. 
  • The risks and benefits of participation. 
  • The financial costs, if any, and if there are assistance programs to help if you need it. 
  • The location of the trial and whether it can be coordinated with your local institution if it isn’t conveniently located—or, if transportation is available. 
  • How often you will need to go to the trial site and how long the trial will last. 
  • Finally, continue to educate yourself, using resources like clinicaltrials.gov. 

Elena: 

And visit powerfulpatients.org/CLL to learn more about clinical trials and CLL research. 

Dr. Singh: 

Thanks for joining us! 

What Barriers Do CLL Patients Face in Accessing Clinical Trials?

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What Barriers Do CLL Patients Face in Accessing Clinical Trials? from Patient Empowerment Network on Vimeo.

When could CLL patients run into barriers to clinical trial access? CLL expert Dr. Adam Kittai explains how access can vary, explains cooperative groups, and discusses the financial benefits of some clinical trials.

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

See More from CLL Clinical Trials 201

Related Resources:

How Can Clinical Trials Be Accessed?

 
 Are Clinical Trials a Logistical Nightmare?

 Why Should CLL Patients Consider Participating in a Clinical Trial?

Transcript:

Katherine:

What do you feel are the barriers to accessing clinical trials for patients?  

Dr. Kittai:

So, unfortunately, a lot of clinical trials are at academic centers, and so there are – and the reason that is, is that the academic centers have the infrastructure to run the clinical trial. So, as we have mentioned before, there’s a lot of visits with a lot of extra science and labs that are done associated with the clinical trial. And a lot of those things and the coordination can only be done at large centers that can open clinical trials and know how to run them.  

Similar explanation could be that that safety monitoring committee that I’d mentioned before, where the academic centers have the infrastructure to ensure safety for the patients. So, access to academic centers is a limitation to enrolling in clinical trials. That being said, there are a lot of centers that are associated with an academic center and do have a lot of the clinical trials that are available at the academic center.  

And there are also cooperative groups. These cooperative groups are called Alliance and ECOG and SWOG. And these cooperative groups are national groups that are headed by multiple academic centers in partnership with pharmaceutical companies and they typically run large Phase III medical trials that help redefine standard of care. And those particular clinical trials are often available at private practices as well.  

Katherine:

Oh, that’s great. So, patients don’t necessarily have to think about traveling to a large educational institution then to become part of the clinical trial?  

Dr. Kittai:

Not always. Not always. Typically for the Phase I, the answer is yes. But for Phase III trials, usually there’s a lot of access available for Phase III trials.  

Katherine:

What would you say to patients who may be hesitant about participating in a trial?  

Dr. Kittai:

I would say that it’s important to at least ask about what’s available. And knowing what’s available and the risks and benefits of going on a clinical trial is how you should make the determination if you should go on a clinical trial.  

Remember what I said earlier that the clinical trial is really meant to help improve safety or efficacy. So, we don’t open clinical trials that we are not hoping to improve one of those two things. And so, that is something that we should be able to put in words to you when inquiring about the clinical trial. What is the goal of this trial, and why do you think it’s going to improve safety or efficacy? And the physician who’s talking the trial with you about it should be able to answer those questions for you. So, if you have some hesitance about going in clinical trials, I would say gather your information first before making a final decision.  

Katherine:

Some patients worry about the financial aspect or impact of a clinical trial. Aren’t trials expensive?  

Dr. Kittai:

So, actually, most clinical trials are less expensive than enrolling a standard of care. So, this is actually a benefit of going on a clinical trial. Often times, the drugs in the clinical trial are a cover. So, that’s something to ask too. And so, if somebody’s having trouble getting access to novel therapy that is looking good in a specific cancer, a clinical trial is actually a way to get access to that drug without paying for it.  

Also, all clinical trials when they’re being developed are looked at by the finance committees of the hospital or wherever it’s being developed. All standard of care options are billed through the patient insurance, but all the extra stuff is usually covered by the pharmaceutical company that’s enrolling those patients onto the trial. Or I should say the supporting the clinical trial.

How Can CLL Patients Find Clinical Trials?

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How Can CLL Patients Find Clinical Trials? from Patient Empowerment Network on Vimeo.

Finding a CLL clinical trial can feel overwhelming for some patients, so where can they start? CLL expert Dr. Adam Kittai shares advice, credible resources, and provides key questions to ask about trial participation.

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

See More from CLL Clinical Trials 201

Related Resources:

How Can Clinical Trials Be Accessed?

 
 Are Clinical Trials a Logistical Nightmare?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

Now that we know what trials are and how they work, how can people find out what trials are available to them? 

Dr. Kittai:

Yeah. So, I’ll come back to this, but once again, talk to your physician. They’ll know what clinical trials are available at whatever site you are seeing them in. If there’s a local academic sector, the academic sector typically has clinical trials available there as well. So, it’s always good to get a second opinion in that regard.  

But one of the open access places that you can find all clinical trials is clinicaltrials.gov. This has all active running clinical trials listed out and anyone can access it. There are other societies out there that often post about clinical trials. So, there’s the CLL Society. It’s a website that you can check out that has a lot of information on there about active clinical trials in CLL. There’s also The Leukemia & Lymphoma Society, the Lymphoma Research Foundation, they all have websites available that have a lot of clinical trials listed and how to access them.  

Katherine:

Are there key questions that you think patients should ask their health care team about participating in a trial?  

Dr. Kittai:

Yeah, for sure. I think one of the key questions to ask is, is the control arm appropriate. So, what do I mean by that? Sometimes people who design a clinical trial will design a trial where the control arm is an easy control arm to beat, meaning that it’s a treatment that we wouldn’t necessarily put you on as standard of care.  

And so, I think this is a real question and an honest question that you should ask your physician prior to enrolling on a trial is, is the control arm something you would give me as standard of care. And if the answer is no, you should really consider not going on that trial or talking about why you would want to go on that trial if the control arm is not something they would put you put you on as standard of care.  

Katherine:

Right. 

Dr. Kittai:

That’s, I think, a key question to ask. And again, asking what phase it is and understanding where we are in the development.  

Are CLL Clinical Trials Safe?

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

What should CLL patients know about clinical trial safety? CLL expert Dr. Adam Kittai explains concerns that patients should discuss with their doctor, the level of research before Phase I studies, and drug safety monitoring.

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

See More from CLL Clinical Trials 201

Related Resources:

Are Clinical Trials Safe?

 Why Should CLL Patients Consider Participating in a Clinical Trial?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

Patients often have questions about safety. What are the risks of clinical trial participation?  

Dr. Kittai:

Yeah, so before anybody enrolls onto a clinical trial, you should sit with your doctor to talk about the pros and cons of entering this clinical trial. One of the things that they will talk to you about is what the expected safety of this drug is. So, you might ask yourself, well, if it’s a phase one study, first in human study, how do they know what toxicity to expect? 

Katherine:

Right. 

Dr. Kittai:

The answer is that there’s a lot of pre-human studies that occur, both in mice and monkeys and other animals, and researchers often have a good idea of what to expect in human. But there is a lot of unknowns in a phase one clinical trial. And after discussing with your doctor the pros and cons of going on a clinical trial and what side effect profile to expect from whatever drug or combination that you are about to be using, usually you go through a consent.  

Usually, you’ll get a packet, it’s about 10 to 20 pages long, written in a way that patients can understand. And it’ll have a list of toxicities that are associated with the research that is occurring. In terms of knowing what adverse events might happen, the consent is key, because it’ll have those all listed out.  

And also having the conversation with your physician about either what they’ve experienced giving this clinical trial, or what is to be expected after this drug had been introduced pre-humans.  

Katherine:

Mm-hmm. Are there protocols in place to protect patients? 

Dr. Kittai:

Yes. So, remember how we talked about in the phase one trials, we dose escalate the drug until we’ve reached some toxicity limit? There are specifically rules written out in a protocol that the doctor must follow that ensures safety for the patients that enroll in clinical trials. And that dose escalation part where we reach a toxic limit is a key part of those phase one trials that is spelled out before you even enroll.  

Usually, there’s also something called a Data Safety Monitoring Committee, as well as other committees that are looking at patients as they are receiving these drugs and move forward on clinical trials to make sure that the investigators are following the protocol as printed. That if anything happens, they document why it happened and fix the problem before it becomes another problem for a patient. So, there are very specific safety rules and a lot of redundancy to protect our patients, because the number one priority is to protect the patient. 

Katherine:

Yeah. I think you’ve already answered this, Dr. Kittai, but how do you know the medicine is safe before a human trial even begins? 

Dr. Kittai:

The answer is you don’t. There is some risk. As I said, they do test it in animals before they give the drug to humans, and they usually start at the lowest dose possible. But there are certain circumstances where there are surprising side effects that are not expected. And so, when you’re entering a first in human, Phase I trial, that is a specific risk that you do need discussed with your physician about before you enroll. 

Katherine:

Can a patient change their mind once they’ve enrolled in a clinical trial? 

Dr. Kittai:

Always. Always.  

Katherine:

Okay. 

Dr. Kittai:

They can come off the clinical trial at any point if they choose to. 

What Are the Types of CLL Clinical Trials?

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What Are the Types of CLL Clinical Trials? from Patient Empowerment Network on Vimeo.

There is not just one type of clinical trial. Expert Dr. Adam Kittai explains the types and how the trials are conducted, including randomized and double-blind studies.

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

See More from CLL Clinical Trials 201

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CLL Clinical Trials: What Are the Phases?

 
 Why Should CLL Patients Consider Participating in a Clinical Trial?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

Okay. You mentioned randomized clinical trials. There are a couple of other clinical trials as well. Would you define them and tell us how they’re different from one another?  

Dr. Kittai:

Yeah. So, a randomized trial is when you enroll onto a study, and you get randomly assigned to either the experimental arm or the control arm. The experimental arm is that new drug that we talked about. And the control arm is usually the standard of care. So, that’s a randomized study. 

And randomized studies are usually Phase III trials, but they can be phase two in some scenarios as well. You have – usually that’s paired with a randomized control study. So, a control study is just there’s a control arm, that’s what that means. But those usually go hand in hand. Those are usually together.  

And then another trial is the double-blind clinical trial. So, a double-blind clinical trial means that once you’re randomized to either the experimental or the control, neither you nor the physician know what drug you’re taking. And that usually is not used in CLL trials. Usually, we know what drug the patient is assigned to. And the reason why that is, is because oftentimes we’re looking out for specific adverse events or toxicities of the drugs we’re implementing at Phase III.  

And then, also, if you’re getting a triplet versus a doublet, meaning three drugs versus two drugs, it’s very hard to blind somebody to know which drug they’re on because obviously you’re getting three drugs versus two drugs. Or if an infusion is involved in one arm but not in the other arm, you obviously know that you’re getting an infusion versus an oral drug. 

Katherine:

Ah, okay. Are there common clinical trial terms that you think patients should know about? 

Dr. Kittai:

I think we covered most of them. So, knowing that phase one is typically the first in the sequence of events that I would ask your physician if this was a first in human study, right, because that comes with some special considerations knowing that you are the first human to receive a new drug is very important. Versus a phase three study where, you know, you know this drug has already gone through phase one and two in development, meaning it’s been given to a lot of patients, and they’re just looking to see if it’s better than standard of care. So, I think knowing those general concepts about what’s the difference between a phase one and a Phase III study, it’s very different. I think it’s important to keep those in mind when talking about clinical trials and discussing with your doctor.  

CLL Clinical Trials: What Are the Phases?

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

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

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

See More from CLL Clinical Trials 201

Related Resources:

What Is a Clinical Trial and What Are the Phases? 

 Why Should CLL Patients Consider Participating in a Clinical Trial?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

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

Dr. Kittai:

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

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

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

Katherine:

Right. 

Dr. Kittai:

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

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

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

Katherine:

Right. 

Dr. Kittai:

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

A CLL Expert Addresses Common Clinical Trial Misconceptions

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

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

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

See More from CLL Clinical Trials 201

Related Resources:

How Can Clinical Trials Be Accessed?

 Why Should CLL Patients Consider Participating in a Clinical Trial?

 Are Clinical Trials Safe?

Transcript:

Katherine:

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

Dr. Kittai:

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

Katherine:

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

Dr. Kittai:

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

Katherine:

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

Dr. Kittai:

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

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

Katherine:

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

Dr. Kittai:

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

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

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

Why Should CLL Patients Consider Participating in a Clinical Trial?

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

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

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

See More from CLL Clinical Trials 201

Related Resources:

How Can Clinical Trials Be Accessed?

 CLL Clinical Trials: What Are the Phases?

 A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

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

Dr. Kittai:

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

Katherine:

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

Dr. Kittai:

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