By Erin Jester
A groundbreaking cancer drug trial designed in part by a University of Florida College of Public Health and Health Professions faculty member has won the prestigious Society for Clinical Trials’ David Sackett Trial of the Year Award.
John Kairalla, Ph.D., research associate professor and associate program director of the Children’s Oncology Group Statistics and Data Center in the Department of Biostatistics and member of the UF Health Cancer Center, serves as senior statistician on the clinical trial, which is ongoing. Two other members of PHHP’s biostatistics department — study statistician Cindy Wang and research coordinator Susan Conway — contributed to the trial.
Since 2008, SCT has awarded the Sackett Trial of the Year Award to a randomized, controlled trial published in the previous calendar year that provides a basis for substantial change in health care and “improves the lot of humankind.”
The award will be presented May 20 in Vancouver, British Columbia, Canada.
The clinical trial, which concluded last year, showed adding the drug blinatumomab to a chemotherapy regimen for children with acute lymphoblastic lymphoma decreased risk of relapse by about two-thirds. These findings represent the biggest breakthrough in childhood cancer treatment in decades, Kairalla said
Results were presented in an oral plenary session on Dec. 7 at the American Society of Hematology’s annual meeting and published the same day in the New England Journal of Medicine.
B-cell acute lymphoblastic leukemia is the most common childhood cancer. While it has a high overall cure rate, relapses of the disease remain a leading cause of death among children.
The National Cancer Institute’s Cancer Therapy Evaluation Program-funded trial began in July 2019 and ended early, in July 2024, after data from the first pre-planned interim analysis showed the drug reduced the relapse rate from 12% in the control group to 4% in the test group — a better outcome than expected.
The regimen is now the ideal standard of care for children with leukemia all over the world.
“It is so rare in the field of biostatistics to be able to see one’s work all of the way through the research pipeline into an appreciable clinical practice, let alone altering the global standard of care in the most common form of childhood cancer,” Kairalla said. “Having the study be recognized as the 2025 winner of the Sackett Trial of the Year Award by the Society for Clinical Trials is a humbling recognition that the research we conduct is worth so much more than grants, publications or individual recognitions, but can save real lives.”
Despite the incredible progress in pediatric leukemia outcomes expected as a result of the study, Kairalla said many challenges remain, including addressing the needs of high-risk subgroups and de-intensifying therapy when possible.
“My motivation is reinvigorated for work on other ongoing clinical trials in acute lymphoblastic leukemia research, as well as current planning and protocol development for future trials,” he said.