Dr. Susan O’Brien, a Hematology-Oncology specialist, explains why patients with chronic lymphocytic leukemia (CLL) should consider a clinical trial and the role trials play in treatment and care.
Dr. Susan O’Brien is the Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center.
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Dr. O’Brien, where do clinical trials fit in in all of this? Should patients discuss clinical trials with their physicians?
Dr. Susan O’Brien:
Absolutely. If we think of these great drugs that we have now, and I’ve mentioned ibrutinib, acalabrutinib, Venetoclax. Before those drugs were available, the only options were chemo. So, that means that people that went on the clinical trial, so let’s say with ibrutinib, have access to a really treatment changing revolutionary drug in CLL years before it was commercially available.
So, clinical trials can be a great way to have access to drugs or combinations. So, for example, right now there are some clinical trials looking at combinations of a BTK inhibitor and a BCL-2 inhibitor. So, the patient might say, “Well, why can’t you give me that combination, doctor?” “Well, technically I could.” If the drug is approved by the FDA, a physician can prescribe it really pretty much anywhere they see fit.
However, does insurance pay for it? That’s the trick. And these are very, very expensive drugs. And so, outside of an FDA approved combination, it probably wouldn’t – I wouldn’t be able to prescribe that combination because it wouldn’t get paid for and it would cost thousands and thousands of dollars. But on a clinical trial in general, the drugs are paid for.
Dr. Susan O’Brien:
And so, clinical trials are testing, for example, combinations now, which are not standard and there are some preliminary data from some of these trials that look really promising, i.e. two drugs may be better than one. There are also patients who, perhaps we’re talking about younger patients now, who have kind of worked their way through the available therapies. And so, they might not have a standard therapy that’s really gonna work for them. And for whatever reason they might not be a good candidate for stem cell transplant.
And so, innovative or totally novel drugs that we don’t have that class of drugs available at all are also being tested in clinical trials and allow people access to them. So, sometimes it’s – I think some people think of it as, well, a last resort if the drugs that are out there don’t work. But don’t think of it that way, because as I mentioned, these combination trials are for people who’ve never had prior therapy, but their disease has progressed enough to need treatment and could potentially offer, at least at a preliminary level, looks like a dynamite combination of drugs.
So, it’s not just for people who failed other drugs or whose disease has failed other drugs. That could be one group that is particularly important for, but even patients who’ve never had treatment, there may be clinical trials that they would be highly interested in participating. And again, it generally has a big financial benefit too, because remember oral drugs have copays for cancer patients.