COLUMBUS - Researchers at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James) and The Ohio State University Wexner Medical Center are conducting a new clinical trial to determine if an oral cancer drug called ibrutinib can also help patients with cancer or other immunocompromised conditions recover from COVID-19.
For this phase II clinical trial, physicians at the OSUCCC - James will enroll up to 78 patients with cancer or a precancerous condition who have been hospitalized as a result of a COVID-19 infection. Patients will be randomized to receive either 14 days of standard treatment plus the study drug ibrutinib, or standard treatment alone.
Ibrutinib is an oral therapy in a class of drugs known as Bruton's tyrosine kinase (BTK) inhibitors. These drugs work by blocking specific chemical reactions in the body involved in cellular processes. Use of this drug is considered experimental for this study; however, ibrutinib is approved by the U.S. Food and Drug Administration for the treatment of certain cancers, including mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma and others.
Jennifer Woyach, MD, an OSUCCC - James hematologist and co-principal investigator of the study, says preliminary data suggests ibrutinib has the potential to reduce rates of respiratory failure and death in COVID-19-infected patients.
"Ibrutinib targets and blocks a specific kinase related to lung inflammation, so we believe it could have real potential to help decrease this inflammation by shutting down the inappropriate cytokine release we see in COVID-19--a sort of overreaction from the immune system that can cause many problems, including life-threatening respiratory challenges," explains Woyach.
Patients will be monitored throughout study treatment with bloodwork to measure inflammatory markers, immune response and other bodily functions.
"Individuals with cancer or certain precancerous conditions can have lower immunity to diseases and infection, due to treatment or the nature of the disease. It is critically important that we perform clinical trials to try to improve COVID-19 care in these patients, because a COVID-19 infection can be even more dangerous for those who are immunocompromised," says Zeinab El Boghdadly, MBBCh, Infectious Disease physician at the Ohio State University Wexner Medical Center and co-principal Investigator for the trial.
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This study is sponsored by the National Cancer Institute and Janssen Scientific Affairs, LLC, manufacturer of the study drug ibrutinib (marketed as Imbruvica®). Woyach has served as a consultant for Janseen Scientific.
To learn more about this and other clinical research at the OSUCCC - James, visit cancer.osu.edu/clinicaltrials or call 1-800-293-5066.
About the OSUCCC - James
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute strives to create a cancer-free world by integrating scientific research with excellence in education and patient-centered care, a strategy that leads to better methods of prevention, detection and treatment. Ohio State is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers and one of only a few centers funded by the NCI to conduct both phase I and phase II clinical trials on novel anticancer drugs sponsored by the NCI. As the cancer program's 356-bed adult patient-care component, The James is one of the top cancer hospitals in the nation as ranked by U.S. News & World Report and has achieved Magnet® designation, the highest honor an organization can receive for quality patient care and professional nursing practice. With 21 floors and more than 1.1 million square feet, The James is a transformational facility that fosters collaboration and integration of cancer research and clinical cancer care.