New Hope

Pelotonia Dollars Support Innovative Clinical Trials

Clinical trials improve cancer care by demonstrating the safety and effectiveness of new treatments, examining treatment strategies and looking at problems associated with therapies so refinements can be made. Here are two examples of Pelotonia-supported clinical trials at the OSUCCC – James. For more information about these and other trials, call The James Line at 1-800-293 5066 or visit cancer.osu.edu.

Researchers Detail Reasons for Discontinuing Ibrutinib Therapy in Some CLL Patients


Basic and clinical research at Ohio State and elsewhere has shown the drug ibrutinib to be highly effective among certain patients with chronic lymphocytic leukemia (CLL), but a study at the OSUCCC – James shows that about 10 percent of patients stopped taking the drug because their disease progressed.

Although CLL, the most common form of adult leukemia, remains incurable, advances in therapy have been made, notably in the emergence of kinase inhibitors such as ibrutinib for patients whose disease has recurred or is resistant to other therapies.

Ibrutinib is the first drug to target a protein called Bruton tyrosine kinase that is essential for CLL cell survival and proliferation. Studies by OSUCCC – James researchers played a key role in gaining FDA approval of ibrutinib to treat certain patients with CLL or mantle cell lymphoma.

Clinical studies of this drug have continued, including a Pelotonia-supported study by Ohio State hematologists Kami Maddocks, MD, Jennifer Woyach, MD, and their colleagues, that described outcomes of patients who discontinued ibrutinb therapy during four sequential clinical trials involving over 300 patients at the OSUCCC – James. The study was published in the Journal of the American Medical Association Oncology.

At a midpoint follow-up of 20 months, the study showed that of 308 patients, 232 remained on ibrutinib, 45 stopped using it due to infection or other adverse events, and 31 stopped using it due to disease progression.

The study concluded that this single-institution experience with ibrutinib confirms it to be an overall highly effective therapy and identifies, for the first time, baseline factors associated with ibrutinib therapy discontinuation.

“These data enhance our understanding of how patients do on ibrutinib long-term and who is likely to relapse,” says Woyach, the study’s senior author and a member of the Leukemia Research Program at the OSUCCC – James. “Understanding which patients are at higher risk helps us select who might benefit from clinical trials on other new agents and combination therapies rather than starting ibrutinib treatment by itself.”

Learning What Works From Women Coping With Chemotherapy


A Pelotonia Idea Grant awarded to OSUCCC – James researcher Kristen Carpenter, PhD, is supporting a clinical trial designed to identify strategies used by women who cope well with harsh chemotherapy side effects during treatment.

“Historically, health psychology focused on bad things that happen to people during cancer treatment—variables that make their outcomes worse,” says Carpenter, a member of the Cancer Control Program at the OSUCCC – James. She notes that her team wants “to learn what helps folks who do well during treatment.”

“Results from several studies in breast cancer have suggested that optimistic patients do a bit better through treatment,” Carpenter says. “Our goal is to investigate the role of optimism and other dispositional variables to ascertain what kinds of things they do that might facilitate better outcomes.”

She and her collaborators also hope to gain insight into whether coping strategies that work well for optimistic people work as well for those who are less optimistic.

“What excites me about this study is that we have an opportunity to look at what patients do naturally to help them through treatment,” she says. “We will look for patterns that we hope will help us develop more individualized, targeted interventions.”

The researchers will assess patients before they begin chemotherapy and several times during treatment to learn which symptoms they experienced and how they coped.

In one phase of the study, patients will complete a daily “diary” of their symptoms and the strategies they use to make themselves feel better, distract themselves or otherwise offset the problem. “The closer we act to the time when something occurs, the more accurate patient reports are,” Carpenter says.

The study will assess participants’ personality, their tendency toward optimism and their general coping style, as well as the presence of depression, anxiety and stress, if any.

“We want to learn which strategies work best and for whom, and how we can develop an intervention that makes sense in the long run,” she adds.

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