A clinical trial using genetic testing to match acute myeloid leukemia (AML) patients with new therapies is now open at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC). The center is one of seven cancer centers nationwide participating in the Beat AML® Master Trial, sponsored by the Leukemia & Lymphoma Society (LLS).
AML, which affects 20,000 Americans annually, is the most lethal of the blood cancers and is responsible for more than 10,000 deaths a year. Despite advances in treating other blood cancers, the standard treatment for AML – a combination of chemotherapies – has changed very little over the past 40 years. Overall prognosis remains poor, with a five-year survival rate below 20 percent for patients age 60 years and older.
"We are very pleased to be able to offer newly diagnosed AML patients age 60 years and older an opportunity to receive investigational drug therapies based on genetic markers associated with their subtype of AML," says Maria R. Baer, MD, professor of medicine at the University of Maryland School of Medicine (UM SOM) and director of hematologic malignancies and co-leader of the experimental therapeutics program at UMGCCC. "This personalized therapy approach, employing genetic testing to help determine treatment, gives us a potentially powerful tool to fight this often deadly blood cancer." Dr. Baer is the principal investigator for the study at UMGCCC.
UMGCCC is the latest cancer center to participate in the Beat AML clinical trial, which is designed to speed US Food and Drug Administration (FDA) approval of new drugs and develop more individualized, effective treatment approaches to the disease. LLS expects the trial will eventually include 500 patients at 15 to 20 sites.
Six other cancer centers are enrolling patients: Memorial Sloan Kettering Cancer Center; Ohio State University Comprehensive Cancer Center; Oregon Health & Science University Knight Cancer Institute; Harold C. Simmons Comprehensive Cancer Center at University of Texas Southwestern: University of Colorado Cancer Center: and University of Chicago Comprehensive Cancer Center. Six major biopharmaceutical companies – Alexion, Boehringer Ingelheim, Celgene, Gilead Sciences, Astellas and Takeda – are providing investigational therapies targeting specific gene mutations.
Newly diagnosed AML patients age 60 years and older are eligible to participate in the study, which is divided into nine treatment "arms." Once patients are enrolled, their bone marrow is analyzed for genetic markers to help researchers determine the most appropriate treatment for their subtype of AML. Patients with no biomarkers are placed in a separate treatment arm, where they also receive an investigational therapy.
"Our faculty does outstanding research into hematologic malignancies and is engaged in many innovative clinical studies aimed at improving treatments for patients with AML and other blood cancers," says UM SOM Dean E. Albert Reece, MD, PhD, MBA, executive vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor. "This is a tremendous opportunity to collaborate with the LLS and other leading cancer centers on this important personalized medicine research initiative."
Other leukemia clinical studies at the cancer center include a trial of a new combination drug therapy to treat AML, based on research done by a UMGCCC scientist; a trial of an immune modulator with chemotherapy for AML; and an immunotherapy trial using a patients' own genetically altered immune cells, or T cells, to treat another form of leukemia, acute lymphoblastic leukemia, or ALL. UMGCCC is also a Center of Excellence for the treatment of myelodysplastic syndromes, a group of bone marrow disorders in which the bone marrow does not produce enough healthy blood cells.