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Should CLL Patients Join Clinical Trials?

Should CLL Patients Join Clinical Trials?
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Published on June 29, 2020

Should CLL Patients Join Clinical Trials? 

Chronic lymphocytic leukemia (CLL) patients should consider enrolling in a clinical trial early in treatment, not as a last resort, according to Dr. Ian Flinn, a CLL expert at Tennessee Oncology in Nashville, Tennessee.

“There's this notion that, ‘I only want to be in a clinical trial if something's not going well,’” he said. “I argue the opposite. If you can get into a well-designed and a good clinical trial even as your first therapy, then I absolutely would encourage that.”

Dr. Flinn participated in a recent town meeting hosted by Patient Power Co-Founders Andrew and Esther Schorr, where they discussed what CLL patients need to know about clinical trials.

He said oftentimes patients in clinical trials have access to therapies before they are widely available. He noted that some of his patients were on ibrutinib (Imbruvica) five or six years before it was approved by the FDA.

He said that even if patients are in a randomized trial and getting the standard treatment (as opposed to the experimental therapy), they still do better than if they weren’t in the trial at all. Part of that could be because of the extra level of care clinical trial patients receive, he said.

“It's the collective wisdom (of the clinical trial team members) about when to treat and when not to treat, how to adjust medicines, and so forth,” he said.

For the most part, clinical trials at Tennessee Oncology have continued uninterrupted during the coronavirus pandemic, Dr. Flinn said. However, some of the trial sponsors have issued guidance, such as shipping medications to patients as opposed to having them come into the office.

Dr. Philip Thompson, a hematologist-oncologist at MD Anderson Cancer Center in Houston, Texas, acknowledged in a recent Patient Power Answers Now program that being in a clinical trial may require frequent hospital visits, which can put cancer patients at higher risk of exposure. He encouraged patients to talk to their doctor about whether a clinical trial is right for them.

“For example, if you run out of standard treatments and you're talking about being on a CAR T compared to a patient who maybe has untreated CLL, where there are lots of good standard of care options,” he said. “Certainly, there are some very interesting frontline treatment options that we have on clinical trials that are not available yet for the standard of care, new combinations and things.”

Dr. Flinn echoed that statement. Clinical trials in previously untreated CLL patients focus on combination therapies, which have been shown to be more effective than single agents.

For example, the CAPTIVATE study, which is ongoing but has stopped recruiting new patients, is evaluating the ibrutinib plus venetoclax (Venclexta) combination therapy in previously untreated CLL patients. Most of the patients (75 percent) achieved undetectable minimal residual disease (MRD) after 12 cycles. MRD measures the small number of cancer cells remaining in the body after treatment.

“…What we’re learning is how to put these (drugs) together in various ways and whether we even need to put them together in combinations,” said Dr. Matthew Davids, associate director of the CLL Center at the Dana-Farber Cancer Institute in Boston, Massachusetts. He spoke to Andrew Schorr at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida.

“We don’t know right now whether it’s better to use these drugs together at the same time or to use one at a time in sequence. So, there’s a lot of studies going on right now trying to answer those questions.”

Dr. Flinn acknowledged that enrolling in a clinical trial is daunting. He noted a written consent form has gone from three pages on an eighth-grade reading level to 15 pages where a patient may feel like he or she needs a lawyer to read and explain it.

“I would just say, ‘Listen, don't lose the forest for the trees, right?” he said. “I mean, you really need to see the big picture, and that's what I do when I sit and talk to patients. I try to have them understand the big picture, the questions that are not all the nitty-gritty about every time you need to draw blood or all those side effects.”

Watch the replay and read the transcript.

~Megan Trusdell


75% of Patients on Ibrutinib-Venetoclax Combo in CLL Achieve Undetectable MRD in CAPTIVATE

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