LLS PedAL

The Leukemia & Lymphoma Society is laying the groundwork for PedAL, a global precision master clinical trial, to usher in a new era of treatment for relapsed and refractory pediatric leukemias. By shifting the paradigm for pediatric leukemia clinical trials to one that is internationally-integrated and collaborative, LLS PedAL aims to accelerate the testing of new precision medicine therapies and change how novel, targeted therapies are developed for the treatment of children with relapsed leukemia.

LLS PedAL will be an  integrated multi-site, multi-therapy master clinical trial with the goal of matching patients to precision treatment based on their unique tumor biology. LLS PedAL seeks to break down silos across sectors, scientific disciplines, institutions, and countries, including the creation of a regulatory and technical infrastructure that fosters large-scale data aggregation and sharing. This new model, which was created based on LLS’s experience launching its Beat AML Master Clinical Trial, aims to create operational and cost efficiencies in study management, make data from different sources interoperable, facilitate easy identification of appropriate patients for new therapies, and consolidate clinical and scientific data from academic medical centers and cooperative groups across the United States and Europe. 

Our Role

To achieve its goals, LLS PedAL requires a robust data infrastructure that supports a wide variety of research and clinical activities, including harmonization of historical data and data mining to match patients to clinical trials. As the leaders of the bioinformatics component of LLS PedAL, our team is developing and deploying the two-part data platform on which the pilot project will run.

GEARBOx (Genomic Eligibility Algorithm at Relapse for Better Outcomes) will address the important task of helping physicians rapidly match patients with relapsed or refractory disease to appropriate clinical trials. Clinical researchers will use this web-based tool to search for trials based on the clinical, immunophenotype, and genomic profiles of their patients. GEARBOx will use a matching algorithm to build a list of appropriate trials based on its database of protocols’ eligibility criteria, connecting patients to lifesaving treatments and reducing burden on physicians.

The second component will power research by bringing together large amounts of pediatric leukemia data into one unified AML data commons. The International Pediatric Acute Myeloid Leukemia Consortium (INTERACT) Data Commons will include historical data to be used in conjunction with new data that is added. All data will be harmonized to a consensus acute myeloid leukemia (AML) data dictionary. These data will be interoperable with other Pediatric Cancer Data Commons disease group data on the Gen3 platform and will power research by including data linkage, cohort outcomes tracking, and analytics tools.

Currently, our team is focusing on several key areas: establishing the AML data dictionary, connecting various data sources and harmonizing historical data for the INTERACT Data Commons, and building and deploying GEARBOx. We are also applying our expertise in the areas of data privacy, security, and legal regulations to develop and follow appropriate policies and procedures to protect patients.