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Study Uses Genetic Testing to Personalize Treatment for Deadly Blood Cancer

| David Kohn

Maria R. Baer, MD

University of Maryland Greenebaum Comprehensive Cancer Center is One of Seven Sites in US to Participate in Beat AML® Master Trial

Aclinical 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; 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.

About the University of Maryland School of Medicine

Commemorating its 210th Anniversary, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 43 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Sciences, and a distinguished recipient of the Albert E. Lasker Award in Medical Research.  With an operating budget of more than $1 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically-based care for more than 1.2 million patients each year. The School has over 2,500 students, residents, and fellows, and nearly $450 million in extramural funding, with more than half of its academic departments ranked in the top 20 among all public medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total workforce of nearly 7,000 individuals. The combined School and Medical System (“University of Maryland Medicine”) has a total budget of $5 billion and an economic impact of nearly $15 billion on the state and local community. The School of Medicine faculty, which ranks as the 8th-highest public medical school in research productivity, is an innovator in translational medicine with 600 active patents and 24 start-up companies. The School works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu/

About the University of Marlene and Stewart Greenebaum Comprehensive Cancer Center

The University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center is a National Cancer Institute-designated Comprehensive Cancer Center in Baltimore. The center is a joint entity of the University of Maryland Medical Center and University of Maryland School of Medicine. It offers a multidisciplinary approach to treating all types of cancer and has an active cancer research program. It is ranked among the top cancer programs in the nation by U.S. News & World Report. www.umgccc.org.

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University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC)

Maria R. Baer, MD

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