In response to studies showing that between 30% and 60% of patients with blood cancer are at risk of death if infected with COVID-19 compared with patients who are cancer-free, the Leukemia & Lymphoma Society (LLS) has announced its launch of the first clinical trial dedicated solely to this vulnerable population.
This trial (LLS Protocol Number: BAML-16-001-COV1) will test acalabrutinib in the treatment of patients diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia, myelodysplastic syndromes, and aplastic anemia—all of whom are often excluded from COVID-19 clinical trials based upon their very low blood cell counts. Other patients with hematologic malignancies, such as those with lymphoma and myeloma, will be eligible as well. All of the study participants will also have tested positive for COVID-19.
Building on a Prior Study
LLS is rapidly leveraging the infrastructure of its Beat AML Master Clinical Trial for this new Beat COVID trial. Beat AML, a precision medicine study launched in 2016 to test multiple drugs at 16 cancer centers for patients with AML, was designed to be adaptable, thus allowing this quick pivot to offer an experimental treatment to address life-threatening coronavirus symptoms in patients with all types of blood cancers.
LLS’s Beat AML Master Clinical Trial launched in 2016, but in March, the pandemic forced the Beat AML cancer centers to pause in enrolling patients. Under this new arrangement, the centers will be able to quickly serve 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 health-care centers are making during the pandemic to address high-risk populations who contract COVID-19.
Acalabrutinib—already approved to treat chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma—is currently 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 solely to patients with hematologic malignancies. Beat COVID will begin as a pilot, treating approximately 60 patients at several of the Beat AML sites.