Tag Archive for: Path to CLL Empowerment

You’re Not a Guinea Pig: Understanding Clinical Trial Participation

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You’re Not a Guinea Pig: Understanding Clinical Trial Participation from Patient Empowerment Network on Vimeo. 

“Will I be a guinea pig if I participate in a clinical trial?” CLL expert Dr. Brian Hill explains the clinical trial process and addresses common patient fears and misconceptions.

Dr. Brian Hill is the Director of the Lymphoid Malignancies Program at Cleveland Clinic. More about this expert.

See More From the Path to CLL Empowerment

 

Transcript:

Dr. Brian Hill:

So, one of the first questions many people ask about being a clinical trial participant is, “Am I a guinea pig?” And what I would say is we’re always practicing medicine. Anything we do, we’re practicing.

But we are always trying to get better whether it’s formally on a trial or not. In terms of side effects of treatment, no matter what – if we have the treatment available, any medication can potentially cause side effects. And it’s very difficult to predict. So, even if you are not on a clinical trial, you could be treated with a standard therapy and potentially have problems or difficulty with it. In terms of clinical trials, it depends where in the sort of journey you are in. If you have never been treated before and now you need to be treated, there are trials that are appropriate for people who are at their first line of treatment.

And this is not typically where we are experimenting with new drugs. So, this is typically where we have established treatments or just sort of trying to compare which one is better. Sometimes these are randomized.

So, there’s a flip of a coin, and you can be assigned to one or another. And I understand why many patients may not want to have their treatment determined by chance. But I would keep in mind that usually if this is being done, it’s been vetted through not just the institution where they are being treated, but often times through review boards throughout the country who basically say, “We think it’s okay to have a flip of a coin decision here because if we have a great treatment which is A and a great treatment which is B and we really don’t know if A or B is better, it’s okay to sort of have a randomization where you may get A or B.”

Sometimes A is the standard and B is likely to be better, but we don’t really know that B is better. And the only way to get the second option would be to be on the clinical trial. So, in that case if you are enrolled, the “worst” option would be the standard.

But it may give you the option of being even better than the standard. And again, if we knew that the second option was better then it wouldn’t be a clinical trial, it would be our standard.  This is sort of how we make progress. And it requires a buy in from the medical community and physicians, but also, it’s important that patients feel comfortable with it. So, that’s kind of for front line treatment. In terms of subsequent therapies, again there are a lot of very good standard treatments available.

And sometimes there are new drugs that are being developed. If the new drug has never been given before to a human, that’s called a Phase One trial. And typically, those are given or offered to people who have had many other lines of therapy and may not have other good options. But sometimes we know that the new drug has been given to people, it’s safe.

The side effect profile is already known even if it hasn’t been given to large numbers of people. And in those cases that would be something around something often called a Phase Two trial where we know it’s safe, but we’d love to see how well it works. And that’s an option for patients as well.

Right. So, outside of talking with your hematologist/oncologist or CLL specialist, there are many other resources for getting information about CLL. The Lymphoma Research Foundation, The Leukemia Lymphoma Society and the CLL Society are all great organizations that have useful websites.

They have 1-800 numbers you can call into. Many of these groups have – I know the CLL Society has a support group in many cities that’s held on a regular basis. And often times there are patient meetings organized through LLS or LRF, the two groups that I mentioned, that allow patients to come and learn from each other and also ask questions of specialists who may be speaking at those events.

How Can Patients Learn About Developing CLL Research?

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How Can Patients Learn About Developing CLL Research? from Patient Empowerment Network on Vimeo. 

Dr. Danielle Brander explains why it’s important for chronic lymphocytic leukemia (CLL) patients to stay up-to-date on developing research and treatment news. Dr. Brander also shares resources for learning more about clinical studies.

Dr. Danielle Brander is Director of the CLL and Lymphoma Clinical Research Program at Duke Cancer Institute. Learn more about Dr. Brander here.

See More From the Path to CLL Empowerment

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Transcript:

Dr. Brander:

I think it’s very important that patients and their caregivers stay informed and advised of opportunities to participate in ongoing research. I think there’s a misconception that with all the favorable progress in treatment options available for CLL, that there’s no longer the need for clinical research participation.

Though, there are a lot of novel options available for CLL, there’s still a lot of ways that we can improve care for patients. That is, there are trials with the next-generation inhibitors or for patients traditionally with harder to treat CLL or may become resistant to the novel agents, there’s a lot of trials looking into how do you combine the novel agents to give patients the best options. And then a lot of the research, too, are not just in the treatments.

But as our science advances into looking at other markers of the CLL cells, or what we call the depth of response, how much CLL you kill with the treatments and how low of a level we can get in terms of detection. This may result in a situation where patients have the opportunity to receive novel treatments, have a really good response, and then potentially stop the treatments and be followed off of therapies, so have the benefit of novel treatment but not with having to go on an ongoing drug forever and ever.

When I talk to a patient about opportunities for clinical trials, I’m really focused on the patient in front of me. That is, I wouldn’t offer or talk about a trial if I didn’t think it potentially could benefit the patient in front of me.

And again, though we’ve had a lot of advances in treatment options, there are certainly a lot of ways that we can engage and hopefully help patients moving forward. There’s been recent studies across all cancers showing that unfortunately a very low percent of patients are offered and enrolled and participating in clinical research studies, and I think it’s really important that patients know there’s a lot of opportunities out there that potentially could benefit them.

The different ways to be advised and informed, again, are some of the resources online educationally for CLL and lymphoma that often post about different sites for clinical trials. There’s a clinical trials.gov web site that all sites in the United States that are enrolling trials with patients have to log clinical trials, and though that has to be updated, it often can be a good beginning site.

But in the end, hopefully the best resource is your treatment team, your oncologist, and your other team that can help point you to what trials might be eligible for you, either at the location where you are or close by.

The last part I’ll point out is though we focus a lot on the treatment clinical trials, in CLL, where patients don’t always need treatment right away or may have treatment and have a response and then have a long period of time afterward, is that many centers are helping to engage patients in research that is not necessarily done during the time of their treatment. Again, to try to understand why some patients have a longer course until they require treatment, or why they might have responded differently, or other ways we can improve their care.

How is a CLL Treatment Path Determined?

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How is a CLL Treatment Path Determined? from Patient Empowerment Network on Vimeo.

Dr. Danielle Brander explains the patient-specific factors and disease-specific factors that are taken into consideration when determining a treatment approach for people with CLL.

Dr. Danielle Brander is Director of the CLL and Lymphoma Clinical Research Program at Duke Cancer Institute. Learn more about Dr. Brander See More From the Path to CLL Empowerment

Transcript:

Dr. Brander:

There are several factors to take in consideration when discussing individualized treatment approaches or options for patients.

Broadly, this can be divided into patient-specific factors, and then CLL-specific factors. And what I mean by that is patient’s age, even for patients very fit, we know from clinical trials that there’s a different processing, tolerability, and benefit of certain chemotherapies and a higher risk of certain side effects, even with the novel therapies as patients advance in age.

There are other patient-specific factors such as there are other medical problems. We often call these comorbidities. These are things like cardiovascular or a heart problem history, diabetes, kidney function differences. A lot of those factors play into individualizing when you know different treatment side effects what might be the best option for patients.

In the CLL-specific factors, these are some of the markers and characteristics that we have talked about in terms of FISH testing, TP53 mutation status, and IGHV mutation status. Based on recent clinical trials for patients receiving first treatment, if there are any changes, which historically chemotherapy didn’t treat the CLL for as long as we would have liked, we tend to err towards the novel agents for sure. And even across all markers, there can be a benefit of the newer drugs such as ibrutinib or venetoclax, or many of the other next-generation inhibitors that are in development. But for sure, patients with deletion 17p or TP53 mutation should never receive chemoimmunotherapy.

There’s a lot of research going into understanding what other CLL-specific markers may benefit for one treatment type versus the next. And we hope that all patients could potentially benefit from clinical trials both in the options that are offered as well as some of this other testing, which is how do you determine which markers are important for patients in the era of the drugs that we have today.