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Who Is a CAR-T Trial Right For?

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Published on March 16, 2020

Key Takeaways

  • Inclusion and exclusion criteria for clinical trials are designed with patient safety in mind.
  • Patients with high-risk features like the chromosome 17p deletion, may qualify for a CAR-T trial if they've had fewer prior treatments than patients without a high-risk feature.
  • Dr. Brander is currently working on a multi-site CAR T-cell clinical trial for CLL patients who have had prior treatment.  

“CAR T-cell studies are really trying to balance the potential benefit from a study with knowing the risk,” says Dr. Danielle Brander, explaining why clinical trials have strict inclusion and exclusion criteria, especially for a newer therapy like CAR T.

Dr. Brander, a chronic lymphocytic leukemia (CLL) expert from Duke Cancer Institute, provides an easy-to-understand explanation of which CLL patients are most likely to qualify for a CAR-T trial, and why. She also discusses a clinical trial she is currently working on for CLL patients who have had prior treatment. Watch now to learn more about this specific type of CLL therapy .  

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Transcript | Who Is a CAR-T Trial Right For?

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:

You are now beginning the trial for CAR T and CLL at Duke. And, so, we have a lot of questions from people in the CLL community. One of them is, “Who is this trial right for? If I’m too old, if I’ve had too many therapies. Or are there other therapies I should have first?” So, really, tell us a little bit about the criteria of who it might be right for. 

Dr. Brander:

Sure. So, in the case of the trial that we are starting to do, this is a sponsored trial, so this has been going on nationally. It was brought up at one of the ASH Meetings. And, as a trial done at multiple sites, there’s always a list for any study, and for this clinical trial too, of what we call inclusion and exclusion criteria. I tell patients it’s really designed as a consensus of, for safety reasons, what patients can be included and what patient factors would exclude patients from trials. And, while that seems like a list and we don’t want to ever feel like we’re trying to exclude patients, it really is done out of a manner of safety. You want to make sure.  

And those criteria are going to be the same at Duke, as any site where a clinical trial is being conducted, as the minimum requirements that patients must have and must not have to safely be considered for the study. And some of that, like I said, is part of the protocol, and that is not really negotiable, because it’s meant as safety. This is a trial for CLL patients so, of course, patients have to meet the diagnostic criteria for being diagnosed with CLL. It also is for patients that have had prior treatment. So, it is not a study for patients that are—certainly not that don’t have any treatment indications. It’s not yet CAR T for CLL, is not yet being considered as a first treatment. 

And, so, this is for patients that have had prior treatment. CAR-T studies, I think this one included, but just to talk more broadly for CLL in addition to looking for patients that have had prior treatment, are really trying to balance the potential benefit from a study with knowing the risk. And, so—and what I mean by that is there are patient factors that would make this appropriate study, and there are the CLL markers. As patients are well aware, there are a lot of—in addition to the diagnosis of CLL—a lot of markers looked at in terms of genomic things missing from the CLL. 

And I just bring that up because, to take the risk of a newer therapy like CAR T, patients and their counseling physicians have to consider the risk of the treatment versus what would the risk of the CLL be to respond to the current treatment. And, so, for example, this and other trials consider if you have what are labeled as high-risk markers such as 17p with a lot of chromosome changes, you might eligible for a newer therapy, like CAR T and the trial, without as many prior therapies. But if you don’t have as high of risk markers that might respond longer to some of the available therapies, then patients might have needed more prior lines of treatment. 

So, that might be a little confusing. But, basically, the number of prior treatments patients need to have had depends on their other markers because of the available therapies and, again, balancing the risk of known, approved therapies versus something in a trial. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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