Leukemia & Lymphoma Society Launches Trial for Blood Cancer Patients with COVID-19

The Leukemia & Lymphoma Society (LLS) is launching the first clinical trial for blood cancer patients at risk of death if infected with the COVID-19 virus.

The trial will test acalabrutinib in patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes and aplastic anemia, all of whom are often excluded from COVID-19 clinical trials based upon very low blood counts. Other blood cancer patients, such as those with lymphoma and myeloma, will be eligible as well. All of the patients will also have tested positive for COVID-19.

LLS is leveraging rapidly 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 acute myeloid leukemia (AML), for this new "Beat COVID" trial.

Through a partnership with AstraZeneca, LLS will be leading the only dedicated clinical trial for blood cancer patients infected with COVID-19. Patients in the trial will receive acalabrutinib (CALQUENCE), a medicine already approved to treat two types of blood cancers, chronic lymphocytic leukemia and relapsed/refractory mantle cell lymphoma, but which shows promise in mitigating some life-threatening effects of COVID-19.

LLS's pioneering Beat AML Master Clinical Trial launched in 2016 but in March the pandemic forced the Beat AML cancer centers to pause enrolling patients for that trial; under this arrangement they quickly will be able to treat patients with all types of blood cancers who are also diagnosed with COVID-19. The "Beat COVID" trial demonstrates the swift and significant adjustments many researchers and healthcare centers are making during the pandemic to address high-risk populations who contract COVID-19.

"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. We are grateful for our partnership with AstraZeneca, and our collaboration with the U.S. Food & Drug Administration, to quickly adapt this ‘Beat COVID’ trial to address the critical need for treatments for blood cancer patients severely sick with COVID-19. 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,” LLS President and CEO Louis J. DeGennaro, Ph.D., said.

Acalabrutinib is already being tested in multiple clinical trials worldwide for patients with COVID-19, both those who are diagnosed with cancer and those who are not. The "Beat COVID" trial, differs from these other trials in that it is dedicated only to blood cancer patients. Beat COVID will begin as a pilot treating approximately 60 patients at several of the Beat AML sites. AstraZeneca already had a connection to the Beat AML Master Clinical Trial as another one of its therapies is being tested in patients with acute myeloid leukemia in that study.

Acalabrutinib is a category of drug called BTK (Bruton's tyrosine kinase) inhibitor. BTK is a protein that triggers the white blood cells of the immune system into action. One of the life-threatening symptoms of COVID-19 is an extreme immune response that causes inflammation frequently resulting in permanent, often fatal damage to lungs and other vital organs.