SOHO 2024 | Considering a patient with CLL for a clinical trial and how to get them involved

So, I think we always talk about clinical trials as being an important part of the therapy options for patients, and particularly for rare diseases such as chronic lymphocytic leukemia. There are different types of trials, and I think that’s really important to specify that towards the patient. So, you know, there are trials that are looking at, of course, standard of care options that might be randomized to an up-and-comer new potential standard of care option. A great example of this is, you know, trials that include, let’s say, venetoclax obintuzumab versus a BTK inhibitor and a BCL-2 inhibitor. So, standard of care, time-limited versus an oral-oral doublet. Now, that could be for anybody in the treatment naive space, right? So, somebody who needs therapy for their disease, for the frontline setting, but you’re giving them good options with either standard of care versus possibly the next standard of care with an oral-oral. That is a great option for all patients. And we would approach any patient who’s treatment naive for something like that, which is standard of care. What about, though, patients who are multiply relapsed? So they’ve gotten all the standard of care options that are available locally in the community or anywhere that are true standard of cares for that patient for their disease, but they’re running out of options. And so now we’re looking at drugs with newer mechanisms of action that we obviously need to find the right dose, look at the safety and efficacy. And so that is obviously for somebody who’s multiply relapsed, who’s run out of options, looking for a newer agent. And we have plenty of those patients who have failed BTK inhibitors, whether that be covalent or non-covalent, and venetoclax-based therapies and need new therapies and are running out of options. And so that’s where you can explore new Phase I/Phase II clinical trials of these newer agents that we’re trying to see if they work for CLL. What is the right dose? What is the efficacy of these agents in patients who are running out of options? So that, you know, trials like BTK degraders, bispecific monoclonal antibodies or any other novel agent that’s being looked at for patients, again, who have had multiple therapies over the course of their disease that are relapsed and refractory. So, different types of clinical trials, depending upon where the person is in their journey with their disease and what they might need for their disease at that point in time. Now, how do you get the patients involved? Well, you know, many of these patients, you know, certainly if there’s not a trial in that person’s area, we would recommend that they be sent to a center who has different clinical trials. Thankfully, the internet is available, and so you can access clinical trials on the websites, clinicaltrials.gov and other websites that are highlighting clinical trials for patients, the Leukemia and Lymphoma Society, CLL Society. There are different patient advocacy groups that have links also to the clinical trials that are available for patients with a particular disease. And so we would point patients in that direction. And then, you know, usually if somebody is, you know, a patient is interested in a particular trial, we sit down and have a conversation about, you know, where they are with their disease and what types of trials potentially are available with what agents and what might be more suitable for them. But that’s how we would normally approach a patient. And then, of course, talk to them about, you know, the risk benefit ratio and the side effects and pros and cons of that particular clinical trial or that particular agent, you know, depending upon what the therapy is on the trial. But that’s what I would recommend if, you know, we would definitely, you know, how we move forward in this field, how we’ve gotten all these agents for CLL or any disease approved is through these clinical trials. And again, some trials might be more suitable for a patient depending upon where they are in their journey. And I would recommend that anybody is definitely a potential to participate in a clinical trial, whether they’ve never had therapy for their CLL or are relapsed/refractory. There’s usually a clinical trial always available if they’re interested. And, of course, always if it’s suitable for them and their disease at that point in time. And also, you know, they also have to be willing to participate in a clinical trial, willing to have extra studies, extra CAT scans and blood work done and able to go back and forth from that center. But I would recommend at any point in somebody’s journey to be possibly eligible and participate in a clinical trial.