Published on July 29, 2020
CLL Clinical Trials For Older Adults: Triplet Combination
Jennifer A. Woyach, MD, Associate Professor, Division of Hematology, The Ohio State University talks with Patient Power co-founder and CLL patient, Andrew Schorr about current CLL clinical trials including one studying the triplet combination of ibrutinab, obinutuzumab and venetoclax in older CLL adult patients.
If you are interested in participating in this study, call The James Line at 800-293-5600 to make an appointment with the principal investigator listed or ask your doctor if you are eligible for this study.
Transcript | Current CLL Clinical Trial for Older Adults
Hello and welcome to Patient Power. I'm Andrew Schorr, living with CLL and getting older. And so, so many CLL patients are older and wonder, well, what are their options? So, there is something called the Alliance Study and the Chair of that Alliance, working on that study is Dr. Jennifer Woyach from the James Cancer Center at Ohio State. So, what is this Alliance study and what could it mean for older CLL patients?
Thanks Andrew. So, we know that older patients with CLL have different needs than those that are younger. They tend to tolerate therapies differently and likely, there are drugs that are more or less effective in older patients versus younger patients. We recently investigated, what is the current best therapy for older CLL patients? On the Alliance, A041202 study, which compared bendamustine (Bendeka) plus rituximab (Rituxan) to ibrutinib (Imbruvica) alone, and ibrutinib plus rituximab. And found that indeed ibrutinib either a given alone or with rituximab was superior to bendamustine plus rituximab in terms of effectiveness. So, to follow that, we started asking the question, well, if ibrutinib is the standard of care or a standard of care for older patients, could we add another drug to that, specifically venetoclax (Venclexta) and get people into deeper remission, so that we can stop therapy?
This was actually based upon a smaller study that we did at Ohio State. It's under the direction of Dr. Kerry Rogers, and this was investigating the triplet regimen of ibrutinib, venetoclax, and obinutuzumab (Gazyva) for either frontline CLL or relapsed/refractory CLL. We found that it was extremely effective and so that led to a triplet combination we're studying in the current Alliance Study, which is Alliance A041702. Where we're comparing a standard care regimen, ibrutinib plus obinutuzumab to ibrutinib plus venetoclax, plus obinutuzumab. And so this study is specifically for people age 70 or older, who have not had previous treatment for their CLL.
So, in the standard therapy arm, patients get six months of obinutuzumab, which is a CD-20 monoclonal antibody and then will take ibrutinib indefinitely. On the experimental arm, patients get that exact regimen plus venetoclax and venetoclax starts after a couple of cycles and then after a year of therapy, patients on that arm will have a response evaluation. And if they have a complete response where we can detect no CLL anywhere, called a Minimal Residual Disease (MRD) negative complete response, they stop all their treatment. And otherwise, they continue on ibrutinib. So, the goal of this study is really to see whether a triplet with venetoclax and ibrutinib is better than ibrutinib plus of obinutuzumab. The study is ongoing. We are hoping to accrue about 500 patients and it started about a year ago. It's actively open at almost 700 sites across the country. So hopefully we'll have some people see this program and be interested in it.
Okay. And I've already been treated so I wouldn't maybe qualify. I am just about 70 so for people who are often 70 or older and develop CLL for the first time, this is something to look at because these are very powerful and effective medicines. And so, what you're looking at is the synergistic effect and that is very attractive. I will mention, years ago, I had the synergistic effect of fludarabine (Fludara), cyclophosphamide (Cytoxan) and rituximab and I got a 17-year remission out of it. So synergy and then being able to stop is very attractive. So, we wish you well with that, Dr. Jennifer Woyach. Thank you for explaining that trial for us and I hope that our patients will look into it, if it may be right for their situation. Thanks for being with us.
Okay. I'm Andrew Schorr. Remember, knowledge can be the best medicine of all.