St. Jude Children’s Research Hospital concluded the Total Therapy Study 16 evidencing the ability to successfully reduce the rate of central nervous system (CNS) relapse to 1.8% for acute lymphoblastic leukemia (ALL) in children.
The Problem: ALL Relapse
Despite modern therapies, 10% of those patients with ALL treaded in the U.S. relapse, dramatically reducing their survival chances. This is a horrific situation for a family and the child.
For the Total 16 Study, the investigators at St. Jude Children’s Research Hospital evaluated interventions aimed at preventing relapse by improving systemic and CNS disease control. Researchers found that adding doses of chemotherapy in the cerebrospinal fluid earlier in care improved CNS control without adding toxicity for high-risk patients.
The predecessor study—Total 15—the rate of CNS relapse for high-risk patients was 5.7%. Under Total 16, the rate of CNS relapse for a similar group of patients was reduced to 1.8%, the lowest among reported studies. As in Total 15, no patient received prophylactic cranial radiation.
A total of 16 enrolled 598 patients age 18 and younger from 2007-2017. This study included all subtypes of ALL, including B-ALL and T-ALL, those with Philadelphia chromosome rearrangements, and infant leukemia, among others, reported St. Jude in their press release. This study was funded by the National Cancer Institute (NCI) and ALSAC, a funding arm of St. Jude’s Children’s Research Hospital.
Total 17 Clinical Trial: Getting More Precise in Stopping Relapse in Children with ALL
St. Jude will launch another ALL clinical trial called Total 17, where they will continue to stratify patients based on their risk of relapse as well as introducing novel molecular targeted and immunotherapies including CAR-T cells.
Clinical Investigator POV
Sima Jeha, MD of St. Jude Departments of Oncology and Global Pediatric Medicine noted in regard to the study “In addition to relapse, infections and other treatment complications are things to keep physicians up at night.” Dr. Jeha represents the kind of hero that keeps TrialSite News mission going noting “Our work will continue until the day when every patient can thrive after treatment.”
Note the study’s other St. Jude authors included Dequing Pei, John Choi, Chang Cheng, John Sandlund, Hiroto Inaba, Jeffrey Rubnitz, Raul Ribeiro, Tanja Gruber, Susana Raimondi, Raja Khan, Jun J. Yang, Charles Mullighan, James Downing, William Evans and Mary Relling. Elaine Coustan-Smith and Dario Campana of the National University of Singapore also contributed to the study.
Call to Action: If you or a loved one as a family member under 18 with acute lymphoblastic leukemia (ALL) consider contacting St. Jude Children’s Research Hospital to learn more about their program.