NEW YORK – The Leukemia and Lymphoma Society on Wednesday said it has launched a master protocol clinical trial to identify targeted treatments for children with difficult-to-treat leukemias based on their cancers' unique biology.
The organization is conducting the trial, dubbed the Pediatric Acute Leukemia Master Clinical Trial (PedAL), in partnership with the National Cancer Institute, Children's Oncology Group, and the European Pediatric Acute Leukemia Foundation. The University of Chicago's Pediatric Cancer Data Commons will lead data collection and consolidation efforts, and deploy a tool, called Genomic Eligibility Algorithm at Relapse for Better Outcomes (GEARBOx), that doctors can use to match pediatric leukemia patients to trials.
LLS is aiming to enroll around 1,000 patients up to age 22 with relapsed or refractory leukemias in PedAL. Pediatric leukemia patients interested in joining the global trial must have their bone marrow and blood samples tested for biomarkers to enable matching to a clinical trial. Screening sites are already open in the US and Canada, and the first therapeutic trial site is at Arkansas Children's Hospital. More therapeutic trial sites will open this year and next.
LLS launched PedAL recognizing the significant need for better treatments for pediatric acute leukemia. The five-year survival rate for children with acute myeloid leukemia is 69 percent, and even when treatments are successful, 70 percent of survivors have chronic, disabling, or life-threatening illnesses over their lifetime. Within PedAL, researchers also hope to create a registry of patients with refractory or relapsed pediatric leukemia and longitudinally track their outcomes.
"With our partners, we will create the largest single source of data for children with acute leukemias and provide the opportunity for families to enroll their children in screening and therapeutic sites across the globe," Edward Kolb, chief of oncology and hematology at Nemours Children's Health in Delaware and co-chair of PedAL, said in a statement. "We want to make PedAL accessible to as many children and their families as possible."