The Leukemia & Lymphoma Society (LLS) has announced the launch of the first clinical trial dedicated to people with blood cancers, including acute myeloid leukemia (AML), who are infected with COVID-19.
The study will be conducted as part of the Beat AML Master Clinical Trial (NCT03013998), a precision medicine study launched in 2016.
The basic idea behind this large study is to use a single “master protocol” for the evaluation of a wide variety of investigational medications in multiple different cancer types. The medications are chosen for each participant based on the exact genetic makeup of the person’s particular cancer.
Now, the Beat AML trial is expanding to include a study — BAML-16-001-COV1 — that will evaluate the cancer medicine acalabrutinib in people with AML, acute lympoblastic leukemia, myelodysplastic syndromes, or aplastic anemia who have tested positive for COVID-19.
In this trial, all participants will get the active medication and none will get a placebo. Participants are being recruited at multiple locations in the U.S. More information can be found here.
Acalabrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor, a type of medication that can prevent the growth of certain immune cells. It is approved by the U.S. Food and Drug Administration under the brand name Calquence (marketed by AstraZeneca) for the treatment of chronic lymphocytic leukemia and relapsed/refractory mantle cell lymphoma, in which immune cells themselves have become cancerous.
In the context of COVID-19, acalabrutinib may be therapeutic because it can reduce the activity of the immune system. Emerging evidence suggests that, in some people with COVID-19, an extreme immune response to the infection can cause serious damage to organs; as such, reducing immune system activity may be therapeutic in people with the pandemic disease.
Investigations into Acalabrutinib as a potential treatment for COVID-19 are underway in other ongoing clinical trials (for example, NCT04380688 and NCT04346199). The new study will be the first clinical trial of the medication dedicated to people with blood cancer. Such patients are at high risk of infection, but are often excluded from COVID-19 clinical trials due to abnormal blood counts.
“This drug was first approved thanks to blood cancer patients participating in clinical trials, so it stands to reason that these same patients should be the beneficiaries if it’s going to work to treat the symptoms of COVID-19, given the high rate of mortality for this population,” John Byrd, MD, chief medical officer of Beat AML, said in a press release.
“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,” added Louis J. DeGennaro, PhD, president and CEO of the LLS.
“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,” DeGennaro said. “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.”