City of Hope is investigating an innovative treatment for patients with cancer and COVID-19 by repurposing leflunomide, an anti-inflammatory drug for rheumatoid arthritis that is inexpensive and has few serious side effects, in a new clinical trial. Patients treated for cancer in the past 2 years may also be eligible.
The U.S. Food and Drug Administration recently approved the start of a phase I trial. City of Hope plans to work with other local medical centers who are treating patients with cancer and SARS-CoV-2, the virus that causes COVID-19, to enroll them in the trial.
For the phase I trial, all patients will receive leflunomide and may also be able to simultaneously receive other standard-of-care treatments for COVID-19. They may receive the antiviral therapy remdesivir. Patients with acute respiratory distress syndrome may receive the steroid dexamethasone, and patients with complications of COVID-19 such as cytokine-release syndrome, which can lead to multiple organ failure, can receive the antibody tocilizumab.
As a comprehensive cancer center, City of Hope has extensive experience treating patients with these therapies, including tocilizumab, which is used to treat cytokine-release syndrome in patients who receive chimeric antigen receptor T-cell therapy.
If the phase I trial is found to be a safe and tolerable treatment, then a phase II randomized, double-blind trial will open at a later date. About half the patients will receive leflunomide with standard-of-care therapies to treat COVID-19, and the other half will receive a placebo and standard-of-care drugs as well.