New study tests shorter treatment cycle for deadly form of leukemia

The Rye Brook-headquartered Leukemia & Lymphoma Society (LLS) announced the dosing of the first patient in a clinical trial investigating whether a shorter course of combination therapy is less toxic while remaining as effective as the FDA-approved regimen in older patients with newly diagnosed acute myeloid leukemia (AML).

According to LLS, this phase 2 sub-study within the nonprofit’s Beat AML Master Clinical Trial will determine if a 14-day cycle of venetoclax and azacitidine, followed by a 14-day break, elicits a similar complete remission rate in AML patients aged 60 years and older who are unable to tolerate intensive induction chemotherapy, versus the FDA-approved two 28-day cycles in a back-to-back sequence, which can prove too toxic for older patients.

Approximately 200 patients will be enrolled onto the trial and will be randomized into either treatment arm. Treatment responses will be compared following two months of therapy. LLS is partnering with Korio, a company that provides randomization and trial supply management, as well as Narrativa to use the company’s artificial intelligence models and automated data analyses.

“The promise of a shorter, less toxic regimen for treating AML can be a gamechanger for older patients,” said Dr. E. Anders (Andy) Kolb, president and CEO at LLS, the nation”™s largest nonprofit funder of blood cancer research. “Infections among this patient population are a major concern and often lead to a disruption in treatment which we want to avoid when we’re dealing with this very aggressive and fast-moving form of leukemia.”