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UNMC part of multi-center drug trial on relapsed acute myeloid leukemia

By News Nov 17, 2020 | 4:02 PM

OMAHA, Neb. – The University of Nebraska Medical Center and Nebraska Medicine are involved in a multi-center clinical trial to learn whether a combination of cancer drugs can eradicate leukemia in patients suffering from relapsed/refractory acute myeloid leukemia (AML).

Vijaya Bhatt, MBBS, associate professor and medical director of the leukemia program in the UNMC Department of Internal Medicine, is leading the study with patients at the Fred & Pamela Buffett Cancer Center. Dr. Bhatt and his team are evaluating whether the drugs, Gemtuzumab and Venetoclax, can kill leukemia stem cells. 

The phase I study, which is sponsored by the Big Ten Cancer Research Consortium, is led by the University of Illinois Cancer Center, and is open to patients 18 to 75 years of age who, at the time of recruitment, have had AML relapse or have not responded to treatment. 

The aim is to enroll 24 patients before April 2021. 

In addition to patients at the Fred & Pamela Buffett Cancer Center and University of Illinois Health, the study is open to patients at Indiana University Melvin and Bren Simon Comprehensive Cancer Center and the University of Michigan Rogel Cancer Center. Dr. Bhatt serves as a co-chair of the Big Ten Cancer Research Consortium Myeloid Malignancies Clinical Trial Working Group.

AML is a serious blood cancer that starts in the blood-forming cells of the bone marrow, and comprises approximately 1% of cancers in the United States. An estimated 19,940 people will be diagnosed with the disease in 2020 with an estimated 11,180 deaths — the majority in adults.

The study will investigate the maximum safe and tolerated dose of this novel combination therapy, as well as include measures designed to evaluate the efficacy of the regimen. The combination of Gemtuzumab and Venetoclax is expected to demonstrate synergy in killing leukemia stem cells.