In this video, Dr. Neil Kay, MD, a hematologist specializing in chronic lymphocytic leukemia (CLL) at the Mayo Clinic, in Rochester, MN, is interviewed by CLL Society founder and Chief Medical Officer, Dr. Brian Koffman, MDCM, a retired family physician and a CLL patient.
The beginnings of this trial came at the outset of the COVID-19 shutdown in early 2020. At that time, there was significant uncertainty about where the virus would go, how it would progress, and its effect on patients. Doctors and patients had little information about how the virus would affect CLL patients.
In a letter to the publication Blood, a group led by Dr. Steven P. Treon, MD, PhD, (a Dana-Farber specialist in the treatment of the rare non-Hodgkin’s lymphoma known as Waldenstrom’s Macroglobulinemia) reported observations which seemed to indicate that patients on ibrutinib progressed better in their COVID-19 outcomes than those patients who were not on the drug. This observational data led Dr. Treon to launch a clinical trial to study the effectiveness of ibrutinib in non-blood cancer patients in reducing the need for supplemental oxygen, including mechanical ventilation, shorten hospital stays and improve survival.
The Mayo Team, will build on the observational nature of Dr. Treon’s work and look at the effect of ibrutinib on the outcomes of CLL patients who contract COVID-19.
November 2020 is the target for the launch of this multi-center clinical trial (Rochester, MN, New York, NY, and a third undisclosed site). There will be two cohorts of patients. The first cohort will include patients who display only mild symptoms of COVID. Clinicians will decide whether the patient will remain on ibrutinib or will discontinue the drug. Medical teams will monitor and record coronavirus disease progress in patients who continued ibrutinib vs. those who stopped.
Medical teams will study patients with moderate disease, defined as those requiring hospitalization but not mechanical ventilation, in the second group. This portion of the trial will be a randomized control trial in which one patient will continue ibrutinib for every patient assigned to the group that will stop the drug.
As with all clinical trials, patients and their physicians will need to agree to participate in this study. There are compelling reasons why patients or their doctors may want them to stay on ibrutinib, including:
- The risk of a CLL flair
- The patient is doing well on ibrutinib
- Early data suggestive that ibrutinib provides some level of immune enhancement compared to reduced immune function in CLL patients treated with drugs other than a Bruton’s Tyrosine Kinase inhibitor.
Conversely, it may be beneficial for some patients to stop ibrutinib if they contract COVID-19. These concerns include:
- Patient age, elderly patients are at higher risk of worse outcomes of COVID
- Risk of atrial fibrillation or hypertension might complicate COVID treatment
- Some indication that ibrutinib impairs macrophage function. Macrophages are the white blood cells responsible for phagocytosis or the “eating up” of bacteria, viruses, and fungi that infect our tissues. Macrophages are one of the first defense mechanisms of our response to infectious diseases.
Researchers believe that this study will help provide information about how to use novel agents to treat CLL during infections or pandemics.
Stay strong, wear your mask, and stay healthy!
Thomas. E. Henry III, MBA, RPh, CPh