St. Jude Children’s Research Hospital’s Total Therapy Study 16 showed a reduced rate of central nervous system relapse in acute lymphoblastic leukemia, according to results published online Oct. 28 in the Journal of Clinical Oncology.
Despite modern therapies, 10% of patients with ALL treated in the United States relapse, which dramatically reduces their chance of survival.
The study 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.
On the predecessor clinical trial (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. These results further supported the conclusion of Total 15 that all children with acute lymphoblastic leukemia can be safely spared prophylactic cranial radiation.
Total 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.
The next St. Jude clinical trial for ALL, Total 17, continues to stratify patients based on their risk of relapse and introduces novel molecular targeted and immunotherapies, including CAR T-cells.
The study’s authors are Sima Jeha, Ching-Hon Pui, 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, Mary Relling and Ching-Hon Pui. Elaine Coustan-Smith and Dario Campana of the National University of Singapore also contributed to the study.
The research at St. Jude was funded by grants from the National Cancer Institute (CA21765, CA36401, CA176063 and P50 GM115279), and ALSAC, the fundraising and awareness organization of St. Jude.
