Published on November 5, 2020
Leukemia and Lymphoma Society Launches Groundbreaking Clinical Trial
The Leukemia & Lymphoma Society (LLS) has launched a clinical trial for blood cancer patients who have tested positive for COVID-19, a population that is among the most vulnerable to the novel coronavirus. The “Beat COVID” trial, the first dedicated only to blood cancer patients, will test acalabrutinib (Calquence) in patients diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes, aplastic anemia, and those with myeloma and lymphoma.
Studies show that 30-60 percent of blood cancer patients are at risk of death if infected with the COVID-19 virus compared to patients who are cancer-free, according to LLS, which is partnering with Calquence manufacturer AstraZeneca for the trial. Blood cancer patients are often excluded from COVID-19 clinical trials based upon very low blood counts, the organization said. For the “Beat COVID” trial, LLS is leveraging the infrastructure of its Beat AML Master Clinical Trial, a precision medicine study launched in 2016 to test multiple drugs at 16 cancer centers for patients with AML. The coronavirus pandemic forced the centers to pause patient enrollment.
"We are extremely proud to be able to respond quickly during this pandemic to help blood cancer patients, using the groundbreaking clinical trial infrastructure we built for Beat AML,” said LLS President and CEO Dr. Louis J. DeGennaro in a September 9 press release. “The Beat AML model has shown we can bring precision medicine to blood cancer patients, and we are hopeful this collaboration will bring vital relief and improve outcomes for these at-risk patients."
“Beat COVID” will begin as a pilot trial treating approximately 60 patients at several of the Beat AML sites. Interested patients should contact an LLS Information Specialist at 1-800-955-4572 or online at Leukemia & Lymphoma Society.
Why is the “Beat COVID” Trial Testing Calquence?
Calquence is a Bruton’s tyrosine kinase (BTK) inhibitor used to treat adult patients with mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma. BTK inhibitors block the B-cell receptor signaling that leukemias and lymphomas use to grow and survive.
Results published in Science Immunology found that the drug reduced markers of inflammation and improved clinical outcomes of COVID-19 patients with severe hypoxia (when the body doesn’t get enough oxygen). One of the life-threatening symptoms of COVID-19 is an extreme immune response that causes inflammation, damaging the lungs and other vital organs.
“Part of what we are learning that makes this so much worse clinically for some people that get this infection is something called cytokine storm,” said Dr. Kerry Rogers in an April 2020 webinar with Patient Power Co-Founder Andrew Schorr. Dr. Rogers is a hematologist-oncologist at The Ohio State University Comprehensive Cancer Center in Columbus, Ohio. “It's an immune activation that causes problems in the body, and it's in response to this virus. So, some of the treatments, not just the potential for use of BTK inhibitors, but things you might have heard of in the news like tocilizumab (Actemra) are geared toward blocking this immune-inflammatory response, hoping that people won't get as sick if their immune system's not as activated.”
Cancer and COVID-19
While blood cancer patients are among the most vulnerable to the novel coronavirus and should take extra precautions to avoid infection, experts are more optimistic now than they were earlier in the pandemic.
“I can certainly tell you; it is absolutely not the case that a person with an underlying hematologic malignancy will die of COVID if they get it,” said Dr. Gail Roboz in an interview with Patient Power host and advocate Ruth Fein last month. Dr. Roboz is the director of the Clinical and Translational Leukemia Program at Weill Cornell Medical Center in New York City. “We thought that in the beginning, that if you have that type of an underlying disease there's no way they'll survive the virus, not true. We have patients with acute leukemias, we have patients with chronic myeloid leukemia, chronic myeloproliferative diseases, lymphomas, who can survive COVID.”
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- Leukemia & Lymphoma Society Beat AML Master Clinical Trial
- Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
- The Leukemia & Lymphoma Society Launches First Clinical Trial Specifically for Blood Cancer Patients with COVID-19
- Inhibition of Bruton tyrosine kinase in patients with severe COVID-19
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