COVID-19's Impact on CLL, Myeloma Clinical Trials

CURE® recently invited patients, survivors, caregivers, advocates and health care professionals to attend its first-ever live webinar, “Hear from the Experts: COVID-19 & Cancer Care for Patients.”

Sponsored by Janssen and Pharmacyclics, the webinar was designed to provide those affected by chronic lymphocytic leukemia (CLL) and myeloma with information and updates as they pertain to the current landscape of cancer care during the uncertain times of the new coronavirus (COVID-19).

Dr. Saad Usmani, chief of the Plasma Disorders Program and director of clinical research in hematologic malignancies at the Levine Cancer Institute served as the moderator for the webinar. Panelists included:

• Dr. Zainab Shahid, medical director of bone marrow transplant infectious diseases at the Levine Cancer Institute
• Dr. Farukh Awan, director of the Lymphoid Malignancies Program at the Harold C. Simmons Comprehensive Cancer Center at UT-Southwest
• Dr. Ian Flinn, director of the Lymphoma Research Program at Sarah Cannon Research Institute
• Dr. Lee Greenberger, chief scientific officer at the Leukemia and Lymphoma Society

In the first part of this series, Dr. Ian Flinn and Dr. Saad Usmani addressed how the new coronavirus has affected stem cell transplants as well as the management of CLL and myeloma clinical trials.

Flinn: At least in our part of the country, we're largely continuing with clinical trials, with some exceptions. For patients with CLL or low-grade lymphoma that need to get started on a therapy, we’re going to start them on a therapy. We’ve tried to pause it or delay it as best we can until we’re through the peak. In Nashville, I think we’re past the peak and we’re starting to go on the downside so we will likely start accruing patients again to CLL trials. Most of them haven't been officially stopped or paused but we asked the individual investigators only to recruit patients and only to start therapy on patients that absolutely need it. We are now starting to do that again.

But for some of the other trials for the patients with aggressive lymphomas or relapsed and refractory disease, we’ve tried to continue as best we can. Some of the sponsors have paused trials for a variety of reasons … but I would say that more than half of our trials continue, and we've been still able to treat patients. For instance, some of the CAR T-cell trials have been paused, but other sponsors have taken a different approach and we’re still treating patients on clinical trials with CAR T cells.

I imagine that it might differ in different parts of the country depending on the risk. Thankfully, we live in a part of the country, at least compared to the Northeast, that has not been struck as nearly as hard as our colleagues in that part of the country. We've been able to continue with some of this work. In talking to colleagues in New York City and elsewhere, that's really been hard or impossible to do.

My guess is that it varies from different parts of the country. Sarah Cannon does have operations in different parts of the country, but we're doing it on a center-by-center basis based on their local capabilities.

Usmani: I think our experience has been the same. We obviously were a little worried with our expected peak to arrive last week. For our trials, specifically the bio-specific monoclonal antibodies, which require observation in-house, there was initial concern about slowing down enrollment on those trials because what if the COVID-19 surge comes in and the hospital is getting overrun, what do you do for those patients who are on those clinical trials when bed availability becomes an issue?

But, clearly, we are not in the same situation as New York or Boston and we had three or four weeks of lead time where we could institute a lot of these workflow policies. We actually went to a two-week on-site, two-week off-site schedule in mid-March with both physicians making a very similar fashion to what was done in Italy and China, going through a Team A, Team B and a Team C approach. It means when you're in-house, you are working really hard in the clinics as well as on the inpatient side, but then during the off-weeks, and you wait for the two-week incubation period if you’re exposed to COVID-19 and you do … that.

But now that we're seeing that plateau, early on, the concerns about cellular therapies, early-phase clinical trials requiring inpatient observation and hospitalization is not as big of a concern.

I just wanted to touch upon a few salient features on the management of our myeloma patients. We have modified our autologous stem cell transplantation schema over the past three or four weeks. We went ahead and collected stem cells but deferred transplantation or auto transplants for patients during the weeks of the surge. That means that, our workload will be heavier starting early summer but at least during the surge the hospital needed beds to take care of those patients or even our hematologic malignancy patients who get COVID-19 would, potentially, occupy those beds.

And then, where we could, we were deferring bisphosphonate therapy for bone health or denosumab infusions. We were also delaying post-transplant vaccinations for patients, as an example. We were also modifying treatment regimens where we could. If a patient needs to come in twice a week for an infusion or that we were just going through twice a month for during that month, as long as their disease was under control, or if they need to come in for IVIG we would delay that. Or if they are getting a monoclonal antibody, we could keep them on the oral part of the regimen and then just delay the monoclonal antibody administration to avoid the COVID-19, or potential COVID-19 exposure to those patients.